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

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RecordFirmDate
M.D.I. ADAPTER (K895549)Custom Connection Corp.1989-11-21
FREEWAY NEBULIZER COMPRESSOR (K895592)Lifecare Services, Inc.1989-11-21
LATEX PATIENT EXAMINATION GLOVE (K895497)Plymouth , Ltd.1989-11-21
LATEX SURGICAL GLOVES (K892922)Millimax Corp.1989-11-21
SAS LATEX EXAMINATION GLOVES (K896217)Sas Rubber Products Co., Ltd.1989-11-21
NET STRETCHER PAD (TM) (K892892)North East Technology1989-11-21
STUDIO UNO (K894061)Eurodent, Inc.1989-11-21
CARIBBEAN LATEX PRODUCTS EXAMINATION GLOVES (K894751)Caribbean Latex Products, Inc.1989-11-21
LATEX EXAMINATION GLOVES (K893937)Sai Latex Private , Ltd.1989-11-21
HWA TEH EXAMINATION GLOVES (K896251)Hwa Teh Industrial Sdn. Bhd.1989-11-21
SOFT SUCTION ADAPTER (K895684)Applied Medical Technologies1989-11-20
ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE (K896310)Acufex Microsurgical, Inc.1989-11-20
EAGLE DS (K895164)American Sterilizer Co.1989-11-17
THE COMFORTABLE CANNULA (K896036)Comfortable Concepts Corp.1989-11-17
LATEX PATIENT EXAMINATION GLOVES (K895716)Lizhu Sanitary Materials Factory1989-11-17
PROTOFLUOR Z (K893038)Helena Laboratories1989-11-17
PATIENT EXAMINATION GLOVES (K895557)Moeller Chemicals, Inc.1989-11-17
LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX) (K893351)China National Medicines & Health Prod. I/E Corp.1989-11-17
SKINTEX LATEX EXAMINATION GLOVES (K895227)Fabrica DE Plasticos Mexicanos Del Sur. S.A.1989-11-16
LATEX EXAMINATION GLOVES (POWDER-FREE/HYPO-ALLER.) (K894497)Safeskin Corp.1989-11-16
LATEX PATIENT EXAMINATION GLOVE (K895023)Beijing Latex Factory1989-11-16
LATEX PATIENT EXAMINATION GLOVES (K895194)Waterwide Sdn. Bhd.1989-11-16
POLY-FLEX LATEX EXAMINATION GLOVES (K895499)Pacific Delta Medical Supply1989-11-16
CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS (K893499)Cmsi1989-11-16
ABTEX OR JUTAMAL LATEX EXAMINATION GLOVES (K895340)Jutamal Industry1989-11-16
AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER* (K896434)United States Surgical, A Division of Tyco Healthc1989-11-16
LATEX PATIENT EXAMINATION GLOVES (K895459)The Emulision Glove Factory of the Thirteenth1989-11-16
QCR SYSTEM I AND QCR SYSTEM II (K893380)Bremer Mfg. & Tool Co., Inc.1989-11-16
V*S*R(TM) SCOPE (K895545)Vsr Enterprises Corp.1989-11-15
STERILE LATEX SURGEON'S GLOVES (K894928)Gigantic International Corp.1989-11-15
LEUKOSPORT(TM) ADHESIVE TAPE (K894367)Beiersdorf, Inc.1989-11-15
BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C (K895034)Yamato Medical Corp.1989-11-15
SMYLON (DENTAL STAIN ERASER) (K891338)The Smylon Co.1989-11-14
ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION (K894712)Gen-Probe, Inc.1989-11-14
ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. (K894711)Gen-Probe, Inc.1989-11-14
ALANINE AMINOTRANSFERASE (ALT) (K896001)American Monitor Corp.1989-11-13
NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. (K896321)Superior Healthcare Group, Inc.1989-11-13
RADKOR DXG-650R (K895969)Radkor, Inc.1989-11-13
ALKALINE PHOSPHATASE, LEUKOCYTE, KIT (K896092)Sigma Chemical Co.1989-11-09
RAPIDEC STAPH (K891004)Dms Products, Inc.1989-11-09
WAKO(TM) AUTOKIT GAMMA-GT (K895984)Wako Chemicals USA, Inc.1989-11-08
SHANNON LATEX MEDICAL GLOVES (K895804)Cashmor Mfg. , Ltd.1989-11-08
REFLUX BED (K896256)Cozcon, Inc.1989-11-08
NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (K892856)Acacia Laboratories, Inc.1989-11-08
HUMAN (IGG) SUBCLASS (EIA) KIT (K895600)The Binding Site, Ltd.1989-11-08
SURGI-BRUSH (K896085)Sparta Surgical Corp.1989-11-08
LATEX EXAMINATION GLOVES (K893350)Pan Africa Exports , Ltd.1989-11-08
HDL SINGLES (K895381)Trace America, Inc.1989-11-08
LATEX EXAMINATION GLOVES (K895552)Jung Hua Co.1989-11-08
SURGEON'S GLOVES (K896327)Productes Del Latex, S.A.1989-11-08
BLOOD GAS SAFETY SYRINGE (K895171)Kronner Medical1989-11-07
LATEX EXAM GLOVES (MFG: CHINA NAT CHEM CONST CORP) (K894194)Invent Ent. (U.S.A.) Corp.1989-11-07
LATEX EXAMINATION GLOVES (K893804)S-P Pantec Co., Ltd.1989-11-07
PATIENT EXAMINATION GLOVES (LATEX) (K892571)Sinopac Marketing, Inc.1989-11-07
PATIENT EXAMINATION GLOVES (LATEX) (K892076)M/S Shanghai Knitwear Import & Export Corp.1989-11-07
INTRASITE CAVITY WOUND DRESSING (K895354)Smith & Nephew United, Inc.1989-11-07
LATEX PATIENT EXAMINATION GLOVES (K894967)Yan Ling Rubber Products Co.1989-11-07
PATIENT EXAMINATION GLOVES (K891182)Raystar Engineering & Construction Sdn Bhd1989-11-07
PATIENT EXAMINATION GLOVES (K893075)Quality Latex Corp. Sdn Bhd1989-11-07
PEMACO 2000 INTRAORAL DENTAL WAX (K895562)Pemaco, Inc.1989-11-06
PEMACO 3000 INTRAORAL DENTAL WAX (K895561)Pemaco, Inc.1989-11-06
PEMACO BITE WAX SHEETS (K895563)Pemaco, Inc.1989-11-06
PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT (K895566)Pemaco, Inc.1989-11-06
PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD (K895564)Pemaco, Inc.1989-11-06
STRAPPED EYE SHIELD (K896172)Eye Garter Company, Inc.1989-11-03
EYE PATCH (K896171)Eye Garter Company, Inc.1989-11-03
PATIENT EXAMINATION GLOVES (LATEX) (K892561)Maxicare Mfg. Corp.1989-11-03
X-RAY DETECTABLE GAUZE SPONGE (K895372)Keilei Intl., Inc.1989-11-03
PATIENT EXAMINATION GLOVES (K894352)Rego Latex Progressive Corp.1989-11-03
POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES (K895669)Safeskin Corp.1989-11-03
FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA (K894176)Precision Hearing Instruments1989-11-03
PATIENT EXAMINATION GLOVES (LATEX) (K891256)Raewiks, Inc.1989-11-03
PATIENT EXAMINATION GLOVES (LATEX) (K892167)Raewiks, Inc.1989-11-03
SANISERV SURGICAL SLUSH SYSTEM (K894006)Saniserv, Inc.1989-11-03
PALESTRANT IRRIGATION AND DRAINAGE SET (K896087)North American Instrument Corp.1989-11-03
MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL (K895819)Medi-Tech, Inc.1989-11-02
PUPIL PATHWAY ANALYZER (PPA) (K895609)Pulse Medical Instruments1989-11-02
2018 ARTERIAL/VENOUS PRESSURE DRESSING (K895845)Advance Medical Designs, Inc.1989-11-01
PIK POCKET(R), MODEL PP-3 (K895259)Teledyne Water Pik1989-11-01
PATIENT EXAMINATION GLOVES (LATEX) (K892138)Shanghai Latex Factory1989-10-31
PATIENT EXAMINATION GLOVES (K894449)Pascorp Newmarket Sdn. Bhd.1989-10-31
MILENIA(TM) FSH (MKFS1,5) (K895005)Diagnostic Products Corp.1989-10-31
LID LOC (K895364)Spectrum Co.1989-10-31
DOUBLE ANTIBODY GLUCAGON (K893975)Diagnostic Products Corp.1989-10-31
PATIENT EXAMINATION GLOVES (K892769)Glw Intl. Corp.1989-10-31
SYSTEMATE(TM) IRON ITEM NUMBER: 65417 (K895249)Em Diagnostic Systems, Inc.1989-10-31
HEDY PATIENT EXAMINATION GLOVES (VINYL) (K891670)Hedd Industry Corp.1989-10-31
'MED-TECH' LATEX EXAMINATION GLOVE (K894552)Med-Tech Rubber & Engineering Industries1989-10-31
HVA EIA KIT YAMASA (K895288)Yamasa Shoy Co., Ltd.1989-10-31
HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE (K895868)Baxter Healthcare Corp1989-10-31
DISPOSABLE LATEX EXAMINATION GLOVES (K891794)Cn Asia Sdn Bhd1989-10-31
STERILE SURGEONS GLOVES (K894256)Chung Shiang Rubber Industrial Co.1989-10-31
CANON AUTO REF-KERATOMETER RK-2 (K895475)Canon USA, Inc.1989-10-31
TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT (K895094)Hybritech, Inc.1989-10-31
LP 400 MICROPLATE READER (K894859)Kallestad Diag, A Div. of Erbamont, Inc.1989-10-31
S.M.P.U. LATEX EXAMINATION GLOVES (K895438)P.T. Surya Milani Plastic Utama1989-10-31
PATIENT EXAMINATION GLOVES (LATEX) (K892163)Canada Packers, Inc.1989-10-31
BAXTER BAFFLED TEE ADAPTER (K895014)Baxter Healthcare Corp1989-10-30
FASTEC 901 AGGLUTINATION PATTERN READER (K895967)Schiff & Co.1989-10-30
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY (K895122)Ciba Corning Diagnostics Corp.1989-10-30
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