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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
ANTIGENZ CHLAMYDIA (K912680)Baxter Diagnostics, Inc.1991-07-22
SURGICAL GLOVES (K910895)Influx Pacific Sdn. Bhd.1991-07-22
BELSCOPE LARYNGOSCOPE (K904918)Avulunga Pty. , Ltd.1991-07-22
ENTREE CANNULA (K911813)Core Dynamics, Inc.1991-07-19
SURGICAL SAW BLADES (K912761)Blairden Precision Instruments, Inc.1991-07-19
PERRY NATURAL POWDER FREE GLOVES (K912797)Smith & Nephew, Inc.1991-07-19
X-MARX (K911873)Macbrud Corp. Medical Div.1991-07-19
MICRO ALBUMIN EIA TEST KIT (K912543)Immuno Diagnostic Center, Inc.1991-07-19
SALTER LABS INFANT MEDIUM CONCENTRATION MASK (K912633)Salter Labs1991-07-19
AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R) (K912024)Wako Chemicals USA, Inc.1991-07-19
TARGET MICROALBUMINURIA TEST (K912246)Texas Immunology, Inc.1991-07-19
ELECTROLYTE CONTROL (K912513)Verichem Laboratories, Inc.1991-07-19
MAGNETIC HDL CHOLESTEROL TEST (K911906)Reference Diagnostics, Inc.1991-07-18
E-Z LIFT CRANK IMAGING TABLE (K912181)Med-Tron Products, Inc.1991-07-17
GUM MASSAGER (K911418)Burn-Henderson Partnership1991-07-17
LINEARITY TEST KITS (K912441)Boehringer Mannheim Corp.1991-07-17
REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 (K912386)Helena Laboratories1991-07-17
SYNERMED PHOSPHORUS REAGENT KIT (K912569)Synermed, Inc.1991-07-17
NUTIP (TM) SYRINGE SHIELD (K911214)Western M/D, Inc.1991-07-17
BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT (K912150)Beckman Instruments, Inc.1991-07-17
SWIVEL HORSESHOE HEADREST (K911918)Codman & Shurtleff, Inc.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
XY IMAGING TABLE (K912135)Med-Tron Products, Inc.1991-07-17
CODMAN PEDIATRIC HORSESHOE HEADREST (K911917)Codman & Shurtleff, Inc.1991-07-17
SOPUR GMBH WHEELCHAIRS (K911119)Sopur GmbH1991-07-16
E-Z LIFT IMAGING TABLE WITH FOOT PUMP (K911564)Med-Tron Products, Inc.1991-07-15
XYZ IMAGING TABLE WITH FOOT PUMP (K911561)Med-Tron Products, Inc.1991-07-15
SURGICAL GLOVES (K911134)Kenwell International , Ltd.1991-07-12
MEDICAL ASSEMBLIES ADULT ANESTHESIA BREATH CIRCUIT (K911736)Medical Assemblies, Inc.1991-07-11
COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST (K910212)Acoustic Imaging Technologies Corp.1991-07-11
ADVANCE SUTURE ABSORBABLE GUT SUTURE (K903174)Advance Suture, Inc.1991-07-10
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT (K910610)Bausch & Lomb, Inc.1991-07-09
ABIODENT PERIOTEMP(R) SYSTEM (K911643)Abiomed, Inc.1991-07-09
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
PICC-FIX (K911070)Sorex Medical1991-07-05
ACCU-VENT(TM) WITH NEEDLE-PRO(TM) (K912043)Concord/Portex1991-07-05
HARDING STERNAL SHIELD (K911407)Harding Medical Devices1991-07-05
ORALCAM (K911594)Charmac Group, Inc.1991-07-03
NEUROCAM (K910967)GE Medical Systems1991-07-03
STERILE PACKAGED POWER INSTRUMENT ACCESSORIES (K911930)United American Medical Co., Inc.1991-07-02
CONICAST, INTRACAST, OMECAST (K912567)Metalor Dental USA Corp.1991-07-02
SMALL BONE FIXATION SYSTEM (K911929)United American Medical Co., Inc.1991-07-02
BETHEL PLUS MULTIPLE NAMES (K912042)Bethel Latex Products, Inc.1991-07-02
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (K912217)Eastman Kodak Company1991-07-01
QUALTEX ISLAND DRESSING (K910657)Deroyal Industries, Inc.1991-07-01
CHEM-LINK DATA BASE MANAGER (K912413)Technicon Instruments Corp.1991-07-01
NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) (K904499)Ackrad Laboratories1991-07-01
ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE (K905450)Vital Signs, Inc.1991-07-01
KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON (K911801)Gds Technology, LLC1991-07-01
KETO-340 II (K912373)Ihara Medics U.S., Inc.1991-07-01
EXTEND TRACK UNIT (K904963)Anthony Chiropractic Clinic, Inc.1991-06-28
EYEOPENER (K904469)Kc Medical Industries1991-06-28
MAXI-SCOPE OR ULTRA-SCOPE (K912128)Seiichi Mfg., Inc.1991-06-28
PHILIPS TELESCAN (K911773)Philips Medical Systems, Inc.1991-06-28
NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER (K910890)Lovell-Schenck, Inc.1991-06-27
LATEX PATIENT EXAMINATION GLOVES, HYPOALLERGENIC (K912083)Sterigard, Inc.1991-06-27
SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID (K911811)Siemens Hearing Instruments, Inc.1991-06-26
PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT (K912570)Phonak, Inc.1991-06-26
SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID (K911810)Siemens Hearing Instruments, Inc.1991-06-26
PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT (K912571)Phonak, Inc.1991-06-26
DELFIA(R) 17 -OH-PROGESTERON KIT (K912026)Pharmacia Diagnostics, Inc.1991-06-25
SLIMCATH (TM) (K903001)Gynopharma, Inc.1991-06-25
CROATEST (R) RHEUMATOID DIAGNOSTIC (K904416)Biotrax, Inc.1991-06-24
CATHETER MOUNTS (K911421)Intersurgical, Inc.1991-06-24
ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM (K911425)Intersurgical, Inc.1991-06-24
COLOR VUE TM- MYCOPLASMA PNEUMONIAE (K910833)Seradyn, Inc.1991-06-24
MODEL 2100 PORTABLE FIELD UNIT (K911506)Dntl Corp.1991-06-24
HARDCOATED PLASTIC FILLING INSTRUMENT (K912149)Premier Dental Products Co.1991-06-24
OBA(TM) READER (K911045)Adeza Biomedical1991-06-24
VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED (K911429)Vitek Systems, Inc.1991-06-24
SONO-VU US(TM) (K904583)E-Z-Em, Inc.1991-06-24
MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM (K905074)Siemens Gammasonics, Inc.1991-06-21
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER (K911262)ETHICON, Inc.1991-06-20
TELEX MODEL TLP, IN-THE-EAR (K912204)Telex Communications, Inc.1991-06-20
VARIOUS X-RAY TUBES (K911695)Comet Ltd. C/O Radiology Resources, Inc.1991-06-19
2710-000 OSCILLATING SAW, GENERAL ASSEMBLY (K905383)Micro Surgical Instruments Corp.1991-06-18
LUNG DIFFUSION GAS MIXTURES (K911471)Norco, Inc.1991-06-18
NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT (K911839)Pantex, Div. Bio-Analysis, Inc.1991-06-18
QM300 CALIBRATOR G PACK (K910885)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR (K912153)Qualitone1991-06-17
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK (K910886)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B (K911280)Shimadzu Medical Systems1991-06-17
MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN (K905306)Virion (U.S.), Inc.1991-06-17
QUALITONE MODEL 48 C-WR-BEHIND THE EAR (K912154)Qualitone1991-06-17
QM300 CONTROL G PACK (K910887)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK (K912321)Nova Biomedical Corp.1991-06-17
HAND CARRIED STRETCHER (K911765)L.E. Phillips Career Development Center, Inc.1991-06-14
SURGICAL RUBBER GLOVES (K911268)Pacificlink Export1991-06-13
ANEMIA I, II (K911984)Ciba Corning Diagnostics Corp.1991-06-13
RUBBER LATEX SURGEONS GLOVES (K910928)Regent Hospital Products1991-06-13
PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 (K911104)Hgm Medical Laser Systems, Inc.1991-06-11
COLLAGEN SHIELD, VARIOUS MODELS (K905825)Chiron Ophthalmics1991-06-10
EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST (K911570)Ortho Diagnostic Systems, Inc.1991-06-10
EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST (K911571)Ortho Diagnostic Systems, Inc.1991-06-10
OSTEOMED IB DRILL (K911937)Osteomed Corp.1991-06-10
ULTRASET CATHETER (K911294)Dhd Diemolding Healthcare Div.1991-06-10
ABUTMENT GLO (K905303)Implant Innovations International, Inc.1991-06-10
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Every clearance here is in the API, with alerts when new ones post.