Atlas FDA

1991

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

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RecordFirmDate
SHBG (K912850)Wien Laboratories, Inc.1991-08-12
CELLABS GIARDIA CEL I.F. TEST (K912152)Celltech Diagnostics , Ltd.1991-08-12
ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 (K912809)Em Diagnostic Systems, Inc.1991-08-12
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT. (K911971)Puritan Bennett Corp.1991-08-09
MOBILE X-RAY FLOOR STAND (K912400)Dntl Corp.1991-08-09
VITAL-PORT(R) PETITE VASCULAR ACCESS SYSTEM (K913350)Med Institute, Inc.1991-08-09
STANDARD S3 (K912305)Metalor Dental USA Corp.1991-08-09
XYZ CRANK IMAGING TABLE (K911691)Med-Tron Products, Inc.1991-08-09
ACS LIQUID THROMBOPLASTIN (K912102)Analytical Control Systems, Inc.1991-08-09
MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K912095)Siemens Medical Solutions USA, Inc.1991-08-09
HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS (K910197)C.R. Bard, Inc.1991-08-09
PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT (K912428)Puritan Bennett Corp.1991-08-09
SOLCHROM-PAL (K912313)Metalor Dental USA Corp.1991-08-09
INSIDE JOB (K912871)3M Health Care, Ltd.1991-08-09
STANDARD S31 (K912307)Metalor Dental USA Corp.1991-08-09
BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS (K910528)Possis Medical, Inc.1991-08-09
VACU 2 (K912302)Metalor Dental USA Corp.1991-08-09
HGM COMBINATION ND:YAG & SOLID STATE GREEN (K910272)Hgm Medical Laser Systems, Inc.1991-08-09
LEAD TERMINAL PIN CAPS, VARIOUS MODELS (K911142)Biotronik, GmbH & Co.1991-08-09
TBD KERATOSCOPE (K912130)Alcon Laboratories1991-08-09
STANDARD S32 (K912308)Metalor Dental USA Corp.1991-08-09
RESPIRONICS REMSTAR WITH REMOTE AND RAMP (K911856)Respironics, Inc.1991-08-09
RADIOACTIVE IODINE-125 SOURCES (K912170)Best Industries1991-08-09
MOTOR MASSAGE PILLOW (K912479)Supreme Import , Ltd.1991-08-09
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 (K911876)Shiley, Inc.1991-08-09
SIMPLATE PEDIATRIC (K911745)Organon Teknika Corp.1991-08-09
MAJOR BASIN TRAY (K912104)Medical Device Inspection Co., Inc.1991-08-09
BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE (K913270)Bivona Medical Technologies1991-08-09
LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA (K905291)Lunar1991-08-09
BARD HYDROGEL-COATED FOLEY CATHETERS (K910195)C.R. Bard, Inc.1991-08-09
INTRAVASCULAR CATHETER SECURMENT DEVICE (K912211)Inman Liebelt Corp.1991-08-09
SELECT NEUROMUSCULAR STIMULATORS (K903434)Medtronic Vascular1991-08-09
CUSTOM PROCEDURE TRAY (K911565)Vanguard Medical Concepts, Inc.1991-08-09
LACERATION TRAY (K912117)Medical Device Inspection Co., Inc.1991-08-09
JEJUNO-CATH KIT (K905677)Health Improvement Assoc.1991-08-09
IDEIA(TM) CHLAMYDIA, MODIFICATION (K911430)Novo Nordisk Diagnostics, Ltd.1991-08-07
FMA TRANSLATOR (K912086)Normandie Group, Inc.1991-08-07
LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING (K912269)Ocular Instruments, Inc.1991-08-07
TUBE HOUSING ASSEMBLIES (K912338)Comet Ltd. C/O Radiology Resources, Inc.1991-08-07
TREATMENT TABLE (K910838)Tri W-G, Inc.1991-08-07
CUFFABLE (K911213)Biomedical Dynamics, Inc.1991-08-07
DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 212 (K912119)A&D Engineering, Inc.1991-08-07
LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING (K912253)Ocular Instruments, Inc.1991-08-07
DIGITAL SPHYGMOMANOMETER MODEL UA-833 (K912118)A&D Engineering, Inc.1991-08-07
PR4 (K911097)Mortara Instrument, Inc.1991-08-07
MITRASHEER TRANSPLANT DRESSING (K911649)Polymint Industrial Co. , Ltd.1991-08-07
TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET (K910558)Terumo Medical Corp.1991-08-07
OVAL CUP BIOPSY FORCEP (K911155)Endovations1991-08-07
DIGITAL SPHYGMOIMANOMETER, MODEL UA-830 (K911049)A&D Engineering, Inc.1991-08-07
SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION (K911105)United States Surgical, A Division of Tyco Healthc1991-08-07
URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE (K912120)Olympus Corp.1991-08-07
MONARK ERGOMETERS (K912227)Quinton, Inc.1991-08-07
LATEX EXAMINATION GLOVES (K913033)Reagent Hospital Prod. , Ltd.1991-08-07
GROUP A STREP POSITIVE AND NEGATIVE CONTROLS (K912868)Quidel Corp.1991-08-07
FLEXIFLO ENTERAL FEEDING TUBE (K910382)Abbott Laboratories1991-08-07
PHILIPS DIAGNOST 96 (K912470)Philips Medical Systems, Inc.1991-08-07
OPERAND LUBRICATING JELLY (K912132)General Medical Co.1991-08-07
MMG BILE BAG (K911129)Medical Technologies of Georgia1991-08-07
LANDERS NOTCHED VITRECTOMY LENS RING (K912268)Ocular Instruments, Inc.1991-08-07
DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE (K912129)Biosearch Medical Products, Inc.1991-08-07
HEMOSPAL KIT B22 (K911603)C.G.H. Medical, Inc.1991-08-07
GUARANTY HAIR REMOVAL SYSTEM (K905125)Stephens Mfg. Co.1991-08-05
ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP (K911521)Andronic Devices, Ltd.1991-08-02
LUMATAG T4 CHEMILUMINESCENCE ASSAY (K911985)London Diagnostics, Inc.1991-08-02
MONOSCOPY(TM) BRAND, DUAL SUCTION/IRRIGATION CONTR (K912750)Dexide, Inc.1991-08-02
PEACE MODEL 100 CUFF MONITOR (K912352)Peace Medical, Inc.1991-08-02
CATHLAB SILICONE BILIARY BALLOON CATHETER (K910917)Cathlab Corp.1991-08-02
HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED (K910950)Vitalog Monitoring,Inc.1991-08-02
SMART-EP (K904926)Intelligent Hearing Systems1991-08-02
OHMEDA MODEL 4700 OXICAP (K911193)Ohmeda Medical1991-08-02
MOUTH TO MASK RESUSCITATOR (K912625)Vital Signs, Inc.1991-08-02
MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM (K911964)Abbott Laboratories1991-08-02
3RD HAND HELPER (K911815)Aaron Medical Industries1991-08-02
STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD (K911637)Personal Products Co.1991-08-02
TECNADYNE SURGI-SQUEEZE INFUSION PUMP (K910926)Tecnadyne Scientific, Inc.1991-08-02
TANGENT IV (K912586)Fischer Imaging Corp.1991-08-02
ECT CARBON FIBER PALLET, MODIFICATION (K912481)Siemens Gammasonics, Inc.1991-08-02
LATEX EXAMINATION GLOVES (K912988)La Glove (M) Sdn. Bhd.1991-08-02
CARDIAC SPECT PALLET (K912286)Siemens Gammasonics, Inc.1991-08-02
BOLUS XENON CIRCUIT (K912626)Vital Signs, Inc.1991-08-02
HEART NEBULIZER POLE CLAMP (K913000)B&B Medical Technologies, Inc.1991-08-02
DYNAVISION 2000 (K911938)Performance Ent.1991-08-02
CALIBRATION KIT (K911264)S & W Medico Teknik1991-08-02
MODIFIED LIFECARE MODEL 175 INFUSER (K912092)Abbott Laboratories1991-08-02
FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES (K912022)Fraass Survival Systems, Inc.1991-08-02
ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE (K911520)Andronic Devices, Ltd.1991-08-02
DUAL COMPARTMENT TPN BAG 3 LITER (K911567)Stedim, Inc.1991-08-02
GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER (K912555)Rts Technology, Inc.1991-08-02
MONOSCOPY(TM) BRAND, ELECTROSURGICAL RAKE (K913104)Dexide, Inc.1991-07-31
HEARING AID, UNITRON MODEL UIK (K912870)Unitron Industries, Inc.1991-07-31
ICON TELERADIOLOGY SYSTEM (K911752)Icon Medical Systems, Inc.1991-07-31
E.T. TAPE II (K912884)B&B Medical Technologies, Inc.1991-07-31
ZOLL PD-1400 PACER/DEFIBRILLATOR (K911956)Zmi Corp.1991-07-31
DEVILBISS MODEL 5000 (K911896)Devilbiss Health Care, Inc.1991-07-31
CODMAN SKULL CLAMP (K912011)Codman & Shurtleff, Inc.1991-07-31
CODMAN LHALO SPLIT RING RETRACTOR SYSTEM (K913233)Codman & Shurtleff, Inc.1991-07-31
OMEGA ANGIOSCOPES (OMEGASCOPES) (K911090)Omega Universal Technologies, Ltd.1991-07-31
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM (K912582)Ciba Corning Diagnostics Corp.1991-07-31
PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE (K912195)Jelenko Co.1991-07-30
RHYTHM (K912938)Stellate Systems1991-07-30
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Every clearance here is in the API, with alerts when new ones post.