Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SWIVEL HORSESHOE HEADREST (K911918)Codman & Shurtleff, Inc.1991-07-17
OLYMPUS AF ANGIOSCOPE SYSTEM (K911278)Olympus Corp.1991-07-17
W-H TOPAIR DENTAL HANDPIECE (K912786)Sabra-The Dental Products Group1991-07-17
AIRSTRIP FIRST AID & POST-OP DRESSING (K911682)Smith & Nephew United, Inc.1991-07-17
SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION (K911996)International Technidyne Corp.1991-07-17
VITALMAX 2100/2200 (K905274)Pace Tech, Inc.1991-07-17
ISE/NA+ (K912648)Boehringer Mannheim Corp.1991-07-17
VISION BG TEST STRIP (K911624)British-American Medical, Inc.1991-07-17
TOWNLEY TOTAL KNEE (TTK) (K904448)Biopro, Inc.1991-07-17
XY IMAGING TABLE (K912135)Med-Tron Products, Inc.1991-07-17
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH (K911500)Shimadzu Medical Systems1991-07-17
12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON (K910144)Physio-Control Corp.1991-07-17
BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH. (K912967)Bivona Medical Technologies1991-07-17
SCISSORS,GRASPERS,FORCEPS (K911754)American Cynamid Co.1991-07-17
VZV IGM TEST (K911301)Gull Laboratories, Inc.1991-07-17
HEPCON HMS WITH BODY SURFACE AREA CALCULATION (K911240)Hemotech, Inc.1991-07-17
CODMAN PEDIATRIC HORSESHOE HEADREST (K911917)Codman & Shurtleff, Inc.1991-07-17
Q-SMART HOLTER SYSTEMS (K910808)Quinton, Inc.1991-07-17
DERMALIGHT PSORACOMB (K903660)Solitec GmbH1991-07-17
M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST) (K911718)Biomet, Inc.1991-07-16
VERSA-STIM ELECTRODE LINE MODIFIED (K911069)Conmedcorp1991-07-16
LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100 (K910418)Graphic Controls Corp.1991-07-16
SOPUR GMBH WHEELCHAIRS (K911119)Sopur GmbH1991-07-16
EMPTY I.V. CONTAINER (K910936)Ellis Pharmaceutical Consulting, Inc.1991-07-16
PATIENT WARMER MODEL 100C (K910915)Developmed Corp.1991-07-16
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL (K911686)Depuy, Inc.1991-07-15
VASCULAR BIOPSY FORCEPS (K910840)Vascular Products, Inc.1991-07-15
FC2000 (K911454)S & S Inficon, Inc.1991-07-15
E-Z LIFT IMAGING TABLE WITH FOOT PUMP (K911564)Med-Tron Products, Inc.1991-07-15
TBD (K910081)Empi1991-07-15
ISE/K+ (K912649)Boehringer Mannheim Corp.1991-07-15
BARD AMBULATORY PUMP TUBING SET (K905713)C.R. Bard, Inc.1991-07-15
VIEWNET (K905578)Imagenet1991-07-15
RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP (K911685)Biomet, Inc.1991-07-15
XYZ IMAGING TABLE WITH FOOT PUMP (K911561)Med-Tron Products, Inc.1991-07-15
ANGIOPLASTY INFLATOR (K911295)Vastek1991-07-12
MEDFLATOR INFLATION SYSTEM (K910958)Medex, Inc.1991-07-12
FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK (K911891)Tecnol New Jersey Wound Care, Inc.1991-07-12
ROTATING HEMOSTATIC VALVE (K911678)Devices For Vascular Intervention, Inc.1991-07-12
EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT (K905778)Baxter Healthcare Corp1991-07-12
SURGICAL GLOVES (K911134)Kenwell International , Ltd.1991-07-12
INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE (K911595)Dow Corning Wright1991-07-12
MEDICAL ASSEMBLIES ADULT ANESTHESIA BREATH CIRCUIT (K911736)Medical Assemblies, Inc.1991-07-11
COMFOR-DENT DENTURE LINER (K910795)Comfort Acrylics Co.1991-07-11
FETAL SCALP SPIRAL ELECTRODE (K911657)Advanced Medical Systems, Inc.1991-07-11
CENTAURI YAG LASER SYST, GYNECOLOGY (K904632)Pfizer Laser Systems1991-07-11
COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST (K910212)Acoustic Imaging Technologies Corp.1991-07-11
MEDICAL ASSEMBLIES FILTER (K911738)Medical Assemblies, Inc.1991-07-11
MEDICAL ASSEMBLIES MASS SPECT MONIT LINE/CONNECT (K911737)Medical Assemblies, Inc.1991-07-11
AMCATH DISPOSABLE MICRO SCISSORS (K912605)Intl. Medical, Inc.1991-07-11
REDFIELD INFRARED COAGULATOR (K911648)Redfield Corp.1991-07-11
HEMOGLOBIN REAGENT (K910745)Toa Medical Electronics USA, Inc.1991-07-11
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER (K910429)Baxter Healthcare Corp1991-07-11
SLEEP I/T-5 AND SLEEP I/T-8 (K904432)Cns, Inc.1991-07-10
CERADELTA (K911671)Metalor Dental USA Corp.1991-07-10
ADVANCE SUTURE ABSORBABLE GUT SUTURE (K903174)Advance Suture, Inc.1991-07-10
HORIZON XL (K911616)Mennen Medical, Inc.1991-07-10
GLOBAL CARE MICRO II (K910244)Globalcare Intl., Inc.1991-07-09
ABL520 BLOOD GAS SYSTEM (K910827)Radiometer America, Inc.1991-07-09
COULTERCLONE (K911793)Coulter Immunology1991-07-09
WATER COLUMN RELIEF VALVE (K904398)Icn Pharmaceuticals, Inc.1991-07-09
ILCO INFRARED LIGHT COAGULATOR (K911600)Holl Meditronics, Inc.1991-07-09
CAPIOX(R) BUBBLE TRAP (K911632)Terumo Medical Corp.1991-07-09
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT (K910610)Bausch & Lomb, Inc.1991-07-09
FX-CABLELOK SYSTEM (K912207)Biodynamic Technologies, Inc.1991-07-09
BIOCERAM DENTAL IMPLANT, SERIES II (K904450)Kyocera America, Inc.1991-07-09
CORDIS OPTA 5 (K905698)Cordis Corp.1991-07-09
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE (K912357)R&D Systems, Inc.1991-07-09
SPACE(TM) 7500 (K912071)F.M. Wiest USA, Inc.1991-07-09
ABIODENT PERIOTEMP(R) SYSTEM (K911643)Abiomed, Inc.1991-07-09
ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE (K900385)Parexel Intl. Corp.1991-07-09
TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES (K911605)Target Therapeutics1991-07-09
MERIDIEN DENTAL SYSTEMS (K903488)Anco Merchandise Co., Ltd.1991-07-09
NHS 2044P BODY AID, HEARING AID (K911183)Magnatone Hearing Aid Corp.1991-07-09
BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES (K911606)Baxter Healthcare Corp1991-07-09
AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM (K912651)Stackhouse Assoc.1991-07-08
FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS (K911907)Tecnol New Jersey Wound Care, Inc.1991-07-08
PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT (K912231)Intl. Immunoassay Laboratories, Inc.1991-07-08
AIM TIBIAL NAIL (K911554)Ace Medical Co.1991-07-08
ZEPHYR INFUSION CATHETER (K911560)Target Therapeutics1991-07-05
EASY EYES TM CONTACT LENS CLEANING MACHINE (K904824)Eaton Medical Corp.1991-07-05
CHEMOTHERAPY CONTAINER (K911576)Bemis Mfg. Co.1991-07-05
REICH SUCTION/IRRIGATION CANNULA (K911164)Marlo Surgical Technology1991-07-05
DISPOSABLE SURGICAL TROCAR WITH SEAL (K911589)Applied Vascular Devices, Inc.1991-07-05
SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA (K910985)Precision Laser Products, Inc.1991-07-05
PICC-FIX (K911070)Sorex Medical1991-07-05
MAGNUM-MEIER RECANALIZATION GUIDEWIRE (K911547)Schneider Intl., Ltd.1991-07-05
ACCU-VENT(TM) WITH NEEDLE-PRO(TM) (K912043)Concord/Portex1991-07-05
INNOFLUOR(TM) VALPROIC ACID REAGENT SET (K911688)Intl. Bioclinical, Inc.1991-07-05
PAL (PROBE FOR ASPIRATION AND LAVAGE) (K911149)Marlo Surgical Technology1991-07-05
ACETATE-FREE DIALYSLATE SOLUTION (K903835)Physio, Inc.1991-07-05
HARDING STERNAL SHIELD (K911407)Harding Medical Devices1991-07-05
PULPDENT ORTHODONTIC BRACKET ADHESIVE (K911286)Pulpdent Corp.1991-07-05
BUD DENTAL IMPLANT SYSTEM (K902331)Bud Industries, Inc.1991-07-05
HH-1119 HEALING HEAD (K903515)Minimatic Implant Technology1991-07-04
LAPAROSCOPIC FORCEPS (K911474)United States Endoscopy Group, Inc.1991-07-03
COIL FIELD EXTENDER (K911800)Resonex, Inc.1991-07-03
COLOCARE (K905798)Helena Laboratories1991-07-03
ALL-PRO 100 (K911291)All-Pro Imaging Corp.1991-07-03
ORALCAM (K911594)Charmac Group, Inc.1991-07-03
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Track 1991 automatically

Every clearance here is in the API, with alerts when new ones post.