Atlas FDA

1989

5,030 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SMALL JOINT HAND INSTRUMENTS (K895685)Leonard Medical, Inc.1989-10-16
MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK (K894914)I-Stat Corp.1989-10-16
FORTRESS MODEL 2001LX ELECTRIC 3-WHEELER (K895692)Fortress Scientific , Ltd.1989-10-16
VIBRA-TRAC TRACTION TABLE (K895382)Vibra-Trac Industries1989-10-16
MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR (K895196)Nidek, Inc.1989-10-16
DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST (K893753)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-16
MUMPS VIRUS (K894624)Bion Ent., Ltd.1989-10-16
OPTICAL CATHETER(TM) INTRODUCER SETS (K895041)Medical Dynamics, Inc.1989-10-16
UNSCENTED MENSTRUAL TAMPON (K894846)Personal Products Co.1989-10-16
STERILE LATEX SURGEON'S GLOVES (K891404)Shinheng Corp.1989-10-16
COPOLYESTER FILM DRESSING (K893647)Tri-State Hospital Supply Corp.1989-10-16
FIAX EB VCA-M TEST KIT (K894932)Whittaker Bioproducts, Inc.1989-10-16
AGAR 4000 NEUROMUSCULAR STIMULATOR (K882387)Solcoor, Inc.1989-10-16
COBAS READY GLUCOSE REAGENT (K895526)Roche Diagnostic Systems, Inc.1989-10-16
ANESTHETIC AGENT MONITOR (K892854)Criticare Systems, Inc.1989-10-13
EMERSON 33-CR CHEST RESPIRATOR (K894649)Emerson Intl. Co.1989-10-13
DEVILBISS MODEL 6610D (K894441)Devilbiss Health Care, Inc.1989-10-13
JOHNSON & JOHNSON TUBE SECUREMENT DEVICE (K895431)Johnson & Johnson Patient Care, Inc.1989-10-13
CONNELL-STEPHENS ENDO ANESS TUBE (K895132)The Traumafuse Co.1989-10-13
MICROMEDICS SURGICAL DRILL SYSTEM (K895739)Micromedics, Inc.1989-10-13
SRI 100 RADIOTHERAPY IMAGING SYSTEM (K894912)Philips Medical Systems, Inc.1989-10-13
PATIENT EXAMINATION GLOVES (LATEX) (K892313)Glove Lines Private , Ltd.1989-10-13
STERILE SURGICAL GOWN (K895667)Clinitech, Inc.1989-10-13
FREEMAN TOTAL HIP SYSTEM RIDGED STEM (K890331)Orthopedic Systems, Inc.1989-10-13
MEDIZIV EPIDURAL SYSTEMS (K894725)Mediziv Medical Devices, Ltd.1989-10-13
ALLPAC(TM) MATERIAL (K894759)Barrier Concepts, Inc.1989-10-13
ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM (K892114)Eclosion, Inc.1989-10-13
BIRD (VDR) SINUSOIDAL PERCUSSIONATORS (K895486)Percussionaire Corp.1989-10-13
MICRO-AIRE HIGH SPEED DRILL (2910-000) (K894606)Micro-Aire Surgical Instruments, Inc.1989-10-13
NON-REBREATHING AIRWAY AND MASK(S) KITS (K891124)Airway Products, Inc.1989-10-13
CITREX LATEX EXAMINATION GLOVES (K895722)Pt Citra Latex Lestari1989-10-13
MANUAL DISPOSABLE PULMONARY RESUSCITATOR (K895169)F.L.W. Plastics, Inc.1989-10-13
BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE (K894613)Bivona Medical Technologies1989-10-13
LIGHT BOND SEALANT WITH FLUORIDE (K894565)Reliance Orthodontic Products, Inc.1989-10-13
SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES (K895604)Medical Design & Manufacturing Corp.1989-10-13
STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. (K894993)Baxter Healthcare Corp1989-10-13
PATIENT EXAMINATION GLOVES (K892311)Southern Rubber Industries Co., Ltd.1989-10-13
UNIVERSAL LIGHT CABLE (K894570)Expanded Optics, Inc.1989-10-13
FREEMAN MODULAR HIP STEM RIDGED VERSION (K890498)Orthopedic Systems, Inc.1989-10-13
HANAULUX(R) 2000 (K895715)W.C. Heraeus GmbH1989-10-13
MYODAC2 BIOFEEDBACK DEVICE (K894840)Thought Technology , Ltd.1989-10-13
LATEX PATIENT EXAMINATION GLOVES (K895743)Rubbertech Industry Co., Ltd.1989-10-13
POCKETED WRAPS #3009 A,B,C (K891210)Pro-Safe Professional Linens, Inc.1989-10-13
ENEMA KIT (K894209)Ledins Herbal Healing Systems1989-10-13
NIPRO DENTAL NEEDLE (K894373)Pharma-Plast USA, Inc.1989-10-13
CARNATION TRACHEOSTOMY MASKS (K894457)Dadsun Corp., Ltd.1989-10-13
MIC NON-STERILE LATEX GLOVES (K891160)Asia Dynamics, Inc.1989-10-13
BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE (K894614)Bivona Medical Technologies1989-10-13
LASER SHIELDING TUBE (K894669)Vitaid, Ltd.1989-10-13
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER (K894286)Ppg Industries, Inc.1989-10-12
P POLYMER (K893990)Pace West1989-10-12
HEMO-ALERT (K893830)Koregon Enterprise, Inc.1989-10-12
CLEARPLAN EASY (K894579)Unipath , Ltd.1989-10-12
OLYMPUS VALVULOTOME W/FIXED TIP (K894496)Olympus Corp.1989-10-12
OMNIFIT CERAMIC MORSE TAPER HEAD (K894694)Osteonics Corp.1989-10-12
CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS (K894389)Catachem, Inc.1989-10-12
CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY (K894988)Ciba Corning Diagnostics Corp.1989-10-12
PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) (K891786)Pioneering Technologies, Inc.1989-10-12
AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER (K895071)Acoustic Imaging1989-10-12
CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION (K894476)Catachem, Inc.1989-10-12
APDYNE PHENOL APPLICATOR KIT (K894369)Apdyne Medical Co.1989-10-12
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION (K894318)Datascope Corp.1989-10-12
PERLIDENT (K894933)Germiphene Corp.1989-10-12
ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP. (K894976)Medtronic Vascular1989-10-12
TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000 (K894540)Physio-Control Corp.1989-10-12
CARE DISP. DIAG. ELECTRODES, SILVER/SILVER (K894462)Labeltape Meditect, Inc.1989-10-12
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER (K894681)Shiley, Inc.1989-10-12
FEM-FLEX FEMORAL ACCESS CANNULATION SET (K891576)Research Medical, Inc.1989-10-12
ULTRANS DISPOSABLE INTRAUTERINE (K882224)Telos Medical Corp.1989-10-12
COUPLANT WARMING DEVICE (K893225)Echo Ultrasound1989-10-12
ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES (K895032)Zmi Corp.1989-10-12
KORN MANDIBULAR ADVANCER (K893482)American Orthodontics1989-10-12
CARE 5000 SYSTEM (K894858)Care Systems, Inc.1989-10-12
AMPLAID A308 CLINICAL AUDIOMETER (K891988)Amplus Corp.1989-10-12
DISPOSABLE PLASTIC VAGINAL SPECULA (K894957)Zinnanti Surgical Instruments, Inc.1989-10-12
VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION) (K894732)Medtronic Vascular1989-10-12
TENZCARE STIMULATOR 6890 (K891992)3M Company1989-10-12
AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID (K890993)Maico Hearing Instruments, Inc.1989-10-12
R2 PACE PAD, MODEL 480 (K895729)Darox Corp.1989-10-12
PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. (K894747)Endosonics Corp.1989-10-12
R2 PACE ADAPTOR CABLE, MODEL 196 (K895728)Darox Corp.1989-10-12
CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54 (K895140)Oticon Corp.1989-10-11
SAFETY SURGEONS GLOVES (K892499)Advance Rubber, Inc.1989-10-11
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS (K892450)Quinton, Inc.1989-10-11
PNEUMOTHORAX KIT, MOTIFICATION (K892640)Arrow Intl., Inc.1989-10-11
HUMIDI-FLEX TM (K885313)Life Design Systems, Inc.1989-10-11
HT-RES RTP SYSTEM (K894706)Adac Laboratories1989-10-11
STUART CD UNIVERSAL ROD CONNECTOR CLAMPS (K894702)Bio-Medical Prosthetics1989-10-11
SURGEON'S GLOVES (K892495)Care-Pro Industries, Inc.1989-10-11
CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 (K894943)Amgen, Inc.1989-10-10
GORE-TEX SURGICAL TAPE (K894580)W. L. Gore & Associates, Inc.1989-10-10
SHAMROCK SAFETY BLOOD COLLECTION SET (K895705)Ryan Medical, Inc.1989-10-10
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM (K894977)Trimedyne, Inc.1989-10-10
OVERDENTURE ATTACHMENT (K891613)Implant Innovations International, Inc.1989-10-10
GYNEGUIDE (K894591)Marlo Surgical Technology1989-10-10
RUBBER LATEX SURGICAL GLOVES, STERILE (K895448)Dah Lee Rubber Industries (Thai) , Ltd.1989-10-10
HYDRAULIC FOOT OPERATED STOOL (K893598)Arthro-Medic, Inc.1989-10-10
BIOTRACK HEMOGLOBIN TEST CARTRIDGE (K895101)Biotrack, Inc.1989-10-10
CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL (K894472)Buckman Co., Inc.1989-10-10
HYDRAULIC IV POLE (K893597)Arthro-Medic, Inc.1989-10-10
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Track 1989 automatically

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