meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
42
Latest Decision
1982-02-18

Clearances · page 147 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K820278 INTRAVASCULAR ADMINISTRATION SET Y FPA Class II 1982-02-18
K813170 ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER Surgeons Choice, Inc. GAG Class II 1982-02-12
K813356 DEVICE FOR REPOSITIONING A BET PATIENT Ali-Oop Co., Inc. FNJ Class I 1982-02-10
K820219 OPEN LOOP INFUSION PUMP Iatric Devices FRN Class II 1982-02-10
K820063 KEOFEED 500 ENTERIC FEEDING PUMP Hedeco FRN Class II 1982-02-10
K820203 FLUID ADMINISTRATIVE SET, AFI Linton Biomed Corp. FPA Class II 1982-02-05
K820142 TUBULAR STOCKINETTE Stan-Pak Ent. FQM Class I 1982-02-05
K813607 ACKRAD N-DO VAGE TUBE Ackrad Laboratories FQH Class II 1982-02-05
K820147 STERI-SHURE General Health Systems, Inc. JOJ Class II 1982-02-05
K813258 ULTIMATE-AIRE Hawkins Intl. FRF Class II 1982-02-05
K820141 BIAS STOCKINETTE Stan-Pak Ent. FQM Class I 1982-02-05
K820134 VIGILON PRIMARY WOUND DRESSING, STERILE C.R. Bard, Inc. KMF Class I 1982-02-05
K813475 XOMED MICRO-IRRIGATOR Xomed, Inc. FQH Class II 1982-02-04
K820004 PLEUROFIX THORACENTESIS KIT Burron Medical Products, Inc. GAZ Class II 1982-02-04
K820018 COMFEEL PROTECTIVE SHEET Telecam Medical Devices KGX Class I 1982-02-04
K820052 SAFETY PINS Stan-Pak Ent. LDQ 1982-02-04
K820165 FLOW MED 311 D.R.O. Medical, Inc. FMG Class II 1982-02-01
K820153 EXACON SCIENTIFIC INSTRUMENTS APS Sat Export Engineering & Trading FLL Class II 1982-02-01
K813562 SYRINGE DRIVER 209 Medix Medical Electronics (U.S.A.), Inc. FRN Class II 1982-02-01
K813506 FARRORS TMJ CASSETTE HOLDER Brell Mar Products, Inc. KXF Class I 1982-01-29
K820094 ELASTIC BANDAGE Stan-Pak Ent. FQM Class I 1982-01-29
K820077 EMERSON THORACIC SUCTION REG. #55-JP J. H. Emerson Co. KDP Class II 1982-01-28
K813646 JMS DISPOSABLE SYRINGE Philadelphia Biologics Center FMF Class II 1982-01-28
K813590 MODEL AS6B INFUSION PUMP Baxter Healthcare Corp FRN Class II 1982-01-28
K813306 CONPHAR DIGITAL THERMOMETER Conphar, Inc. FLL Class II 1982-01-28
K813648 JMS NEEDLE & MAC JECT Philadelphia Biologics Center FMI Class II 1982-01-28
K813239 OXYGENAIRE NURING INCUBATOR Vickers America Medical Corp. FMZ Class II 1982-01-28
K813649 PBC NEEDLE Philadelphia Biologics Center FMI Class II 1982-01-28
K810185 IRRIGATION SYRINGE Karoco Intl. FQH Class II 1982-01-25
K813408 SAGE 2200 STERILE SPECIMEN CONTAINER Sage Products, Inc. FMT Class II 1982-01-25
K820073 OPEN LOOP AMBULATORY INSULIN INFUSION Cardiac Pacemakers, Inc. FRN Class II 1982-01-25
K813647 PBC SYRINGE Philadelphia Biologics Center FMF Class II 1982-01-25
K813473 5B SLAVE MODULE SYRINGE PUMP Baxter Healthcare Corp FRN Class II 1982-01-22
K813639 SERIES 400 DISPOSABLE TEMPERATURE PROBE Yellow Springs Instrument Co., Inc. FLL Class II 1982-01-22
K813394 DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM Cox-Uphuff Intl. GCX Class II 1982-01-22
K813238 NEOCARE BABY-CONTROLLED INCUBATOR Vickers America Medical Corp. FMZ Class II 1982-01-22
K813364 MEDICAL TAPE (MULTIPLE) Cederroth, Inc. USA KGX Class I 1982-01-19
K813361 ADHESIVE STRIP(MULTIPLE) Cederroth, Inc. USA KGX Class I 1982-01-18
K813545 HYPOSERMIC NEEDLES Optical Micro Systems, Inc. FMI Class II 1982-01-12
K813396 VERSCHLUBSTOPFEN COMB-CLOSING STOPPER Burron Medical Products, Inc. FOZ Class II 1982-01-12
K813402 WA-2000 TEMPERATURE INDICATOR Wallach Surgical Devices, Inc. FLL Class II 1982-01-12
K813345 CRITIKON I.V. CATHETER PLACEMENT UNIT Critikon Company, LLC FOZ Class II 1982-01-12
K813468 ACC-U-THERM TEMPERATURE MONITOR Diatek, Inc. FLL Class II 1982-01-07
K813454 I.V. FILTER-PREVENT Pioneer Viggo, Inc. FPB Class II 1982-01-05
K813445 IV FILTERSET 5 MICROMETER Imed Corp. FPB Class II 1982-01-05
K813519 NON-ABSORBENT TOWELS Cunningham Woodland, Inc. KME Class I 1982-01-05
K813455 PUMP & DETECTOR Medlog GmbH Marketing Services FRN Class II 1982-01-05
K813446 IV FILTERSET 0.22 MICROMETER Imed Corp. FPB Class II 1982-01-05
K813480 MONOJECT M560 60CC SYRINGES Sherwood Medical Co. FMF Class II 1982-01-05
K813437 PAN SET Sterile Design, Inc. FRG Class II 1981-12-31
K813201 CASTLE #3241 GAS AERATOR Sybron Corp. FLI Class II 1981-12-31
K813259 IN-STOPPER (INJECTION CAP Burron Medical Products, Inc. FPA Class II 1981-12-31
K813403 FLO-GARD 8000 INFUSION PUMP SYSTEM Travenol Laboratories, S.A. FRN Class II 1981-12-31
K813260 TRACHEOSTOMY CARE TRAY E.M. Adams LDQ 1981-12-31
K813407 AIR MATTRESS Trans World Agency, Inc. FNM Class II 1981-12-31
K813333 ALPHATEMP CLINICAL THERMOMETER Alpha Omega Engineering Corp. FLL Class II 1981-12-31
K813202 THERMALOG S STEAM STERILIZATION INTEGRA Bio-Medical Sciences, Inc. JOJ Class II 1981-12-31
K813092 ACCUPRO I.V. ADMINISTRATION SET American Mcgaw FPA Class II 1981-12-31
K812928 VACU-FIL TRANSFER SET American Pharmaseal Div. Ahsc LHI Class II 1981-12-30
K813435 BAXA ADLI SEAL Baxa Corp., Sub. of Cook Group, Inc. KPE Class II 1981-12-18
K813423 THERMOMETER SHEATHS Abco Dealers, Inc. FLK Class II 1981-12-18
K813424 THERMOMETERS Abco Dealers, Inc. FLK Class II 1981-12-18
K813421 NON-ADHER PADS Abco Dealers, Inc. KGX Class I 1981-12-18
K813409 MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER Yellow Springs Instrument Co., Inc. FLL Class II 1981-12-18
K813319 ASPIRATOR VENTURI SYSTEM MODEL 55-JV J. H. Emerson Co. GCX Class II 1981-12-14
K813105 PRESSURE INFUSION PUMP Calbio, Inc. KZD Class I 1981-12-14
K813029 VALVED SURGICAL ASPIRATORS Imedix GCX Class II 1981-12-14
K813214 INFANT PHOTOTHERAPY MASK Montrose Phototherapy Supply FOK Class I 1981-12-09
K813161 FLO TEM II (BLOOD/FLUID WARMER Datachem, Inc. LGZ Class II 1981-12-09
K813188 INFANT PHOTOTHERAPY LIGHT Montrose Phototherapy Supply LBI Class II 1981-12-09
K812479 POSTURE MIRROR Maddak, Inc. LDQ 1981-12-09
K813124 ETHICON* SKIN CLOSURE TAPE ETHICON, Inc. KGX Class I 1981-12-08
K813049 AQUANOMICS, #HHU100 Cooper-Hewitt Electric Co. KMG Class II 1981-12-02
K813045 AQUANOMICS, #SP36SF Cooper-Hewitt Electric Co. KMG Class II 1981-12-02
K813050 AQUANOMICS, #MP4SF Cooper-Hewitt Electric Co. KMG Class II 1981-12-02
K813194 AUTO-SYRINGE SUB-CUTEANEOUS SET Baxter Healthcare Corp FPA Class II 1981-12-02
K812898 PE-01 ELECTRONIC INFUSION PUMP Egnell, Inc. FRN Class II 1981-12-02
K813046 AQUANOMICS, #HHU60 Cooper-Hewitt Electric Co. KMG Class II 1981-12-02
K813226 GEL FLOTATION MATTRESS Jefferson Industries, Inc. IKY Class I 1981-12-02
K813047 AQUANOMICS, MINI 60L Cooper-Hewitt Electric Co. KMG Class II 1981-12-02
K812473 HEAD PROTECTOR Maddak, Inc. FMQ Class I 1981-12-02
K813048 AQUANOMICS, #MP2SF Cooper-Hewitt Electric Co. KMG Class II 1981-12-02
K813263 PATIENT UNDERPAD The Buckeye Cellulose Corp. KME Class I 1981-11-27
K813228 CONNECTING TUBE Northern Medical Industries BYY Class II 1981-11-27
K813175 20CC GLASS CONTROL SYRINGE Abco Dealers, Inc. FMF Class II 1981-11-27
K813027 STERILE IRRIGATING SYRINGES, KITS,TRAY Welcon, Inc. KYZ Class I 1981-11-20
K812555 DISPOSABLE SUTURE REMOVAL SCISSORS Medcare Products JOK Class I 1981-11-16
K812845 SURGICAL SUCTION INSTRUMENTS-DISPOS. Abco Dealers, Inc. GCX Class II 1981-11-16
K813066 ARGYLE YANKAUER SUCTION TUBE Sherwood Medical Co. GCX Class II 1981-11-16
K813083 VENOFIX SCALP VEIN SET Burron Medical Products, Inc. FPA Class II 1981-11-16
K812312 STERILE WATER 4OZ. Superior Plastic Products Corp. JOL Class II 1981-11-13
K812888 SYRINGE, PISTON Frisco Products, Inc. FMF Class II 1981-11-10
K813014 PROTECT-O-SEAL Tri-Med, Inc. JOJ Class II 1981-11-10
K812137 B-D HEPARINIZED LONGDWEL I.V. CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic FOZ Class II 1981-11-06
K812856 CHEMICAL INDICATORS Sterilization Technical Services, Inc. JOJ Class II 1981-11-06
K812910 MEDISYSTEMS NEEDLES & SYRINGES Medisystems Corp. FMI Class II 1981-11-06
K812927 ARTERIOGRAM TRAY American Pharmaseal Div. Ahsc FMG Class II 1981-11-06
K812981 FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) Venusa , Ltd. FPK Class II 1981-11-06
K813012 STERILE BASIN SETS Medspec Corp. LDQ 1981-11-06
K813001 FIBRI-FILTER 20 Tri-Med, Inc. FPB Class II 1981-11-06

15,723 clearances in the General Hospital panel. Data: openFDA.