FDA Product Code
FDA Product Code LDQ — Clearance Directory
- Device Class
- —
- Assigned Panel
- General Hospital
510(k) Clearances — 81 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K993797 | EC-7701 FLUID WARMING CABINET | Enthermics Medical Systems, Inc. | 2000-01-20 | Traditional | PDF ↗ |
| K992258 | HOT SHOT FLUID WARMER IV FLUIDS | Infra-Med Technologies, Inc. | 2000-01-12 | Traditional | PDF ↗ |
| K981032 | PIV SYSTEM | Medical Solutions, Inc. | 1998-09-02 | Traditional | PDF ↗ |
| K973747 | CONTROLLED TEMPERATURE CABINET SYSTEM | Smith | 1998-05-07 | Traditional | PDF ↗ |
| K955661 | ACU-HALT | Glederer & Co., Inc. | 1996-12-30 | Traditional | PDF ↗ |
| K955776 | ACU-LAB | Glederer & Co., Inc. | 1996-06-05 | Traditional | PDF ↗ |
| K945374 | ACU-HALT | Eva-Health USA, Inc. | 1995-08-09 | Traditional | PDF ↗ |
| K944961 | PERSONAL ALARM SYSTEM (PAS) | Cytoprobe Corp. | 1995-08-07 | Traditional | PDF ↗ |
| K942810 | PALCO LABS COLD POUCH | Palco Laboratories, Inc. | 1995-06-28 | Traditional | PDF ↗ |
| K930884 | MEDICAL PROCEDURE TRAY, MODIFICATION | Enpak Medical Corp. | 1995-03-21 | Traditional | PDF ↗ |
| K934703 | MEDICOOL PROTECTALL | Avc Regulatory Compliance/Technical Services | 1994-01-26 | Traditional | PDF ↗ |
| K925593 | NORTEC STERILE WATER FOR DEVICE IRRIGATION | North American Sterilization & Packaging Co. | 1993-12-03 | Traditional | PDF ↗ |
| K925588 | NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI | North American Sterilization & Packaging Co. | 1993-12-03 | Traditional | PDF ↗ |
| K932714 | ELECTRONIC GLOVE INTEGRITY MONITOR (EGIM) | Surface Mount Technology, Inc. | 1993-12-01 | Traditional | PDF ↗ |
| K931153 | ELPER(TM) BARRIER INTEGRITY MONITORING | Igea, S.R.L. | 1993-11-18 | Traditional | PDF ↗ |
| K924837 | DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET | Associated Ent., Inc. | 1993-10-12 | Traditional | PDF ↗ |
| K930514 | SURGIC-ALERT MONITOR | Novatec Medical Products, Inc.--Glove Monitor | 1993-08-19 | Traditional | PDF ↗ |
| K915636 | GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. | Associated Ent., Inc. | 1992-07-13 | Traditional | PDF ↗ |
| K915662 | BARRIER INTEGRITY MONITOR | Incomed, Inc. | 1992-06-25 | Traditional | PDF ↗ |
| K913696 | GLOVE-CHEK PORTABLE FLUID LEAKAGE SENSING DEVICE | Vertex Technical Group, Inc. | 1992-02-18 | Traditional | PDF ↗ |
| K911955 | OLYMPIC WARMETTE | Olympic Medical Corp. | 1991-07-19 | Traditional | PDF ↗ |
| K902410 | MEDICAL PROCEDURE TRAY | Sorex Medical | 1990-11-20 | Traditional | PDF ↗ |
| K904598 | ACCU PATH STERILE LABEL | Accu-Path | 1990-10-30 | Traditional | PDF ↗ |
| K902682 | STICK-GARD STERILE CAP | Integrated Medical Systems, Inc. | 1990-09-26 | Traditional | PDF ↗ |
| K901237 | GLOVE LEAK DETECTOR | Utah Medical Products, Inc. | 1990-08-21 | Traditional | PDF ↗ |
| K901321 | SHARP-SAFE, BIODEGRADEABLE,DISP., NEEDLE DISP. BOX | Sharp Safe, Inc. | 1990-05-11 | Traditional | PDF ↗ |
| K901486 | WEINSTEIN STYLE INSTRUMENT HOLDER | David Ayres Medical Co. | 1990-05-02 | Traditional | PDF ↗ |
| K895674 | MEDICOOL, CONTAINER FOR STORING INSULIN | Medicool, Inc. | 1990-01-11 | Traditional | PDF ↗ |
| K894570 | UNIVERSAL LIGHT CABLE | Expanded Optics, Inc. | 1989-10-13 | Traditional | PDF ↗ |
| K891023 | SIEMENS CEILING STAND 800F, 800 AND 810 | Siemens Medical Electronics | 1989-07-25 | Traditional | PDF ↗ |
| K892052 | SARNS MEDICAL CART | 3M Company | 1989-06-15 | Traditional | PDF ↗ |
| K885055 | INSU COOL | Dynex Trading Co. | 1989-04-26 | Traditional | PDF ↗ |
| K884630 | MULTI-PURPOSE HOLDER | Med-Dex Intl. | 1988-11-22 | Traditional | PDF ↗ |
| K882388 | MR. RAZOR II TWIN | Burney Products Corp. | 1988-07-13 | Traditional | PDF ↗ |
| K880048 | BLADE, SURGICAL PREP RAZOR STRAIGHT | Crescent Corp. | 1988-03-04 | Traditional | PDF ↗ |
| K874186 | BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE | Busse Hospital Disposables, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K864015 | STERILABELS | Diversatronics, Inc. | 1986-12-12 | Traditional | PDF ↗ |
| K863633 | SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES | Biological & Environmental Control Laboratories | 1986-10-16 | Traditional | PDF ↗ |
| K854441 | STUART GILMAN'S WEIGHT LOSS PLAN | Alpha Therapeutic Corp. | 1986-02-10 | Traditional | PDF ↗ |
| K853185 | CUDDLE CUSHION | The Cuddle Co. | 1985-08-20 | Traditional | PDF ↗ |
| K851390 | STERILE GENERAL HOSPITAL SUPPLIES | Biological & Environmental Control Laboratories | 1985-05-29 | Traditional | PDF ↗ |
| K851276 | ACTION PAC | South Mountain Medical | 1985-05-15 | Traditional | PDF ↗ |
| K842016 | DISPOS. POLY APRONS | Abco Dealers, Inc. | 1984-07-03 | Traditional | PDF ↗ |
| K834062 | STERILE LABELS | Devon Industries, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K834063 | STERILE RUBBER BANDS | Devon Industries, Inc. | 1983-12-22 | Traditional | PDF ↗ |
| K832272 | TOURNIQUET CUFF PRESSURE MONITOR #TCPM | Electromedics, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K831799 | PLASTIC DISPOSABLE RAZOR | I M, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K822484 | INFECTION CONTROL TOWEL | American Threshold Industries, Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K821396 | OUT-RITE WASTE DISPOSABLE BAG | Kleen Test Products | 1982-06-09 | Traditional | PDF ↗ |
| K813566 | CARDIO-BAND | Cardio-Band, Inc. | 1982-02-22 | Traditional | PDF ↗ |
| K820052 | SAFETY PINS | Stan-Pak Ent. | 1982-02-04 | Traditional | PDF ↗ |
| K813260 | TRACHEOSTOMY CARE TRAY | E.M. Adams | 1981-12-31 | Traditional | PDF ↗ |
| K812479 | POSTURE MIRROR | Maddak, Inc. | 1981-12-09 | Traditional | PDF ↗ |
| K813012 | STERILE BASIN SETS | Medspec Corp. | 1981-11-06 | Traditional | PDF ↗ |
| K812482 | FOAM WEDGE | Maddak, Inc. | 1981-09-24 | Traditional | PDF ↗ |
| K812216 | CUDDLE CAP | Darcy, Inc. | 1981-08-20 | Traditional | PDF ↗ |
| K811088 | DRESSING TRAY MERCY HOSPITAL | Cunningham Woodland, Inc. | 1981-05-08 | Traditional | PDF ↗ |
| K811091 | MINOR DRESSING TRAY | Cunningham Woodland, Inc. | 1981-05-08 | Traditional | PDF ↗ |
| K811090 | MAJOR DRESSING TRAY | Cunningham Woodland, Inc. | 1981-05-08 | Traditional | PDF ↗ |
| K811089 | ONE STEP PREP KIT | Cunningham Woodland, Inc. | 1981-05-08 | Traditional | PDF ↗ |
| K810570 | DRESSING CHANGE TRAY-MEDIUM | Associated Medical Products Co. | 1981-03-30 | Traditional | PDF ↗ |
| K802837 | DR. MICHAEL'S FOOT HELPER | Dr. Michael'S Foot-Care Products | 1980-12-10 | Traditional | PDF ↗ |
| K802041 | AMPCO SHAVE PREP TRAYS, CAT.#SP4020 | Associated Medical Products Co. | 1980-10-23 | Traditional | PDF ↗ |
| K802366 | NU-BORN BABY BATH KIT | American Hospital Supply Corp. | 1980-10-10 | Traditional | PDF ↗ |
| K802043 | AMPCO SKIN SCRUB TRAYS, CAT.#SS843 | Associated Medical Products Co. | 1980-09-16 | Traditional | PDF ↗ |
| K802042 | AMPCO SKIN SCRUB TRAYS, CAT.#SS824 | Associated Medical Products Co. | 1980-09-16 | Traditional | PDF ↗ |
| K802003 | PLASTIC DISPOSABLE RAZOR CAT.#1017,1018 | Pollak (Intl.), Ltd. | 1980-09-09 | Traditional | PDF ↗ |
| K802044 | AMPCO SKIN SCRUB TRAYS, CAT.#SS612 | Associated Medical Products Co. | 1980-09-09 | Traditional | PDF ↗ |
| K801421 | TUBE HOLDER | Devon Industries, Inc. | 1980-07-28 | Traditional | PDF ↗ |
| K791798 | CONPHAR SURGICAL RAZORR | Conphar, Inc. | 1980-02-01 | Traditional | PDF ↗ |
| K790504 | SANDEE SANDING BLOCK | Dr. Bertram L. Steel | 1979-06-11 | Traditional | PDF ↗ |
| K790085 | KAGER TRAPDUST | Kager Intl. | 1979-05-29 | Traditional | PDF ↗ |
| K781437 | SURGICAL PREP RAZOR | Warren J. Grosjean | 1978-12-05 | Traditional | PDF ↗ |
| K772275 | TOILET SAFETY RAIL | Med Fusion Systems, Inc. | 1978-03-14 | Traditional | PDF ↗ |
| K772276 | RAISED TOILET SEAT | Med Fusion Systems, Inc. | 1978-03-14 | Traditional | PDF ↗ |
| K772403 | CUT-DOWN BUILT-UP TOILET SEAT | Fred Sammons, Inc. | 1978-02-21 | Traditional | PDF ↗ |
| K770381 | ISOLATION KIT | American Hospital Supply Corp. | 1977-04-05 | Traditional | PDF ↗ |
| K760328 | RAZOR, DISPOSABLE | Devon Industries, Inc. | 1976-08-11 | Traditional | PDF ↗ |
| K760342 | RAZOR, SCHICK DISPOSABLE | Parke-Davis Co. | 1976-08-11 | Traditional | PDF ↗ |
| K760073 | BASIN, WASH, 6-QT RECTANGULAR | Bemis Health Care | 1976-07-20 | Traditional | PDF ↗ |
| K760052 | KIT, PREP SHAVE | M-C Ind., Inc. | 1976-07-16 | Traditional | PDF ↗ |
Product code LDQ · · General Hospital. Data: openFDA.