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

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RecordFirmDate
FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135) (K884631)Xomed, Inc.1989-03-22
NEEDLE EXTENSIONS (K891035)Zinnanti Surgical Instruments, Inc.1989-03-22
PATIENT EXAMINATION GLOVES (K891232)Supergrade Healthcare Products Sdn. Bhd.1989-03-22
ASPIRATING AND IRRIGATING CYSTS NEEDLES (K885283)Go Medical Industries Pty. , Ltd.1989-03-22
LOCKING WIRE GUIDE STYLET (K890820)Medical Engineering and Development Institute1989-03-22
SURGIMAX (LATEX EXAM GLOVES) (K890149)National Dental Supply, Inc.1989-03-22
IQ/QCA PHOSPHORUS (K891218)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-03-22
MICROTRAK CHLAMYDIA EIA (K890196)Syva Co.1989-03-22
PATIENT EXAMINATION GLOVES (LATEX) (K891245)Terang Nusa Sdn Bhd1989-03-22
CAMPION LASER FORCEPS (K891348)Simpson/Basye, Inc.1989-03-22
PATIENT EXAMINATION GLOVES (LATEX) (K891209)Chung Yuan Trading Co., Ltd.1989-03-22
PATIENT EXAMINATION GLOVE (K891132)Phoenix Medical Technology, Inc.1989-03-22
DEFEND LATEX EXAMINATION GLOVES (K891257)Carl Parker Associates, Inc.1989-03-22
ROTO FIT BIOPSY FORCEPS (K891043)Zinnanti Surgical Instruments, Inc.1989-03-22
MIYA SPECULUM (K891041)Zinnanti Surgical Instruments, Inc.1989-03-22
PATIENT EXAMINATION GLOVES (LATEX) (K891153)K.B. Latex Products Sdn. Bhd.1989-03-22
MID-LEVEL IGG KIT CAT. NO. 9315 (K891299)Helena Laboratories1989-03-22
LATEX EXAMINATION GLOVES (K891207)Chung Yuan Rubber & Plastics Co.1989-03-22
COBAS MFC (K885292)Roche Diagnostic Systems, Inc.1989-03-22
PATIENT EXAMINATION GLOVE (LATEX) (K891271)Dr. Boo Co., Ltd.1989-03-22
CARY-BLAIR TRANSPORT SYSTEM (K885245)Precision Biologicals, Inc.1989-03-21
SAF FECAL COLLECTION KIT (K885244)Precision Biologicals, Inc.1989-03-21
LATEX EXAMINATION GLOVES (K891204)Advance Rubber, Inc.1989-03-21
PATIENT EXAMINATION GLOVES (LATEX) (K891208)Cho FU Industrial Co., Ltd.1989-03-21
PATIENT EXAMINATION GLOVES (LATEX) (K891242)Dr. Boo Co., Ltd.1989-03-21
BIOTROL URINE PROTEINS REAGENT (K890846)Biotrol, USA, Inc.1989-03-21
AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) (K890708)Amersham Corp.1989-03-20
OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING (K890011)Life Design Systems, Inc.1989-03-20
VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY (K891038)Zinnanti Surgical Instruments, Inc.1989-03-17
TISCHLER BIOPSY FORCEPS (K891034)Zinnanti Surgical Instruments, Inc.1989-03-17
HEADS TRUE BRUSH (K890812)Mcs Trading Co.1989-03-17
MASSAGING PICK FOR ORAL HYGIENE (K885189)Dentek Corp.1989-03-17
CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL (K891029)Zinnanti Surgical Instruments, Inc.1989-03-17
HOOD NASAL SPLINT (K890599)Hood Laboratories1989-03-17
AIR WATER SYRINGE TIP SHIELD (K884220)Steri-Shield Products, Inc.1989-03-17
LATEX EXAMINATION GLOVES (K891003)Ruhn Chang Industrial Co., Ltd.1989-03-17
CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A (K890703)Oticon Corp.1989-03-17
ZEPPELIN SCISSORS (K891049)Zinnanti Surgical Instruments, Inc.1989-03-17
IUD HOOKS - SIMPLE, UNIVERSAL AND SKLAR (K891030)Zinnanti Surgical Instruments, Inc.1989-03-17
DENTAL LAMP HANDLE COVER (K884223)Steri-Shield Products, Inc.1989-03-17
ZSI BIOPSY FORCEPS (K891027)Zinnanti Surgical Instruments, Inc.1989-03-17
BRACKET TABLE ARM COVER (K884219)Steri-Shield Products, Inc.1989-03-17
LASER SPECULA (K891044)Zinnanti Surgical Instruments, Inc.1989-03-17
THE CLARK LIP SHIELD (K890581)American Orthodontics1989-03-17
SANI-SLEEVE DRAPE FOR DENTAL USE (K885299)Nieusma R & D, Inc.1989-03-16
BIOSONIC ULTRASONIC CLEANING SYSTEM (K884660)Whaledent Intl. Div. Ipco1989-03-16
PLAKOF (K890910)Ximex, Ltd.1989-03-16
EIA READER MODEL EL301 (K890854)Bio-Tek Instruments, Inc.1989-03-16
RIA-GNOST PROGESTERONE (K890836)Cambridge Medical Technology1989-03-16
GRAM STAIN CONTROL SLIDE (K890718)Scientific Device Laboratory, Inc.1989-03-16
SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B (K891154)Atlantic Antibodies1989-03-16
DEFEND LATEX EXAMINATION GLOVES (K891157)Carl Parker Associates, Inc.1989-03-16
LATEX EXAMINATION GLOVES (K891065)Modern Rubber Industrial Co., Ltd.1989-03-16
STARTRAC (K890793)Unisen, Inc.1989-03-16
CRYPTOSPORIDIUM CONTROL SLIDE (K890670)Scientific Device Laboratory, Inc.1989-03-16
RECONDITIONED ASTRA (TM) 8 (K883298)Associated Electro-Medical Services, Inc.1989-03-16
RECONDITIONED ASTRA(TM) 4 (K883350)Associated Electro-Medical Services, Inc.1989-03-16
RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109) (K890414)Amersham Corp.1989-03-15
TOTAL KNEE CPM (K885182)Invacare Corp.1989-03-15
RIATRAC PLUS (K890470)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-03-15
BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES (K890566)Medi-Source, Inc.1989-03-15
THERMO-PACK (K890924)Medical Manufacturers, Inc.1989-03-14
MEDSURG GREENE NEEDLE (K885145)Medsurg Industries, Inc.1989-03-14
SONY VIDEO GRAPHIC PRINTER UP-850 (K890826)Sony Corp. of America1989-03-14
SURGICAL GLOVES (K884622)Globe Ent., Inc.1989-03-14
VITALON MATRESS MASSAGE MODEL M-MX (K890923)Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.1989-03-14
MICK 200-TP AND MICK TP NEEDLE (K890341)Mick Radio-Nuclear Instruments, Inc.1989-03-14
SINGLE PATIENT USE NASAL (CPAP) CIRCUIT (K890193)Puritan Bennett Corp.1989-03-14
STERILE PATIENT EXAMINATION GLOVE (K891103)Boston Medical Corp.1989-03-14
FLORIDA PROBE PERIODONTAL PROBE (K890493)Florida Probe Corp.1989-03-13
RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE (K890089)Gen-Probe, Inc.1989-03-13
PROGENE MICROALBUMINURIA SCREEN (K882538)Progene Corp.1989-03-13
LIPASE SR LIQUID STABLE REAGENT SET (K885078)Medical Analysis Systems, Inc.1989-03-13
20/20 ORTHODONTIC CERAMIC BRACKET (K890145)American Orthodontics1989-03-13
HI CHEM WASH CONCENTRATE REAGENT #88805 (K890578)Hichem Diagnostics1989-03-10
DRY TIPS (K890734)Microcopy, Div. Neo-Flo, Inc.1989-03-10
CLINISTAT CHOLESTEROL REAGENT TEST (K884757)Heraeus Kulzer, Inc.1989-03-10
GUARDS LATEX & SAFE-CONTACT EXAMINATION GLOVES (K890538)Boston Medical Corp.1989-03-10
TRIGLYCERIDES - GPO REAGENT (K890337)Alpkem Corp.1989-03-09
BTE HEARING AID OTICON MODEL: E42P (K890704)Oticon Corp.1989-03-09
OPTIFIELD I AND II AUTOMATED PERIMETERS (K884867)Optimed, Inc.1989-03-09
ALASTIGARD (K890529)Unitek Corp.1989-03-09
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER (K884897)Mennen Medical, Inc.1989-03-09
KENLOR LIQUID URINE CONTROL (K890577)Kenlor Industries, Inc.1989-03-09
CALIUS-ISABEL CANOVAS SUNGLASSES (K890081)Roseburg SA1989-03-09
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL: (K890957)Hycor Biomedical, Inc.1989-03-09
KENLOR HUMAN SPINAL FLUID CONTROL LIQUID (K890576)Kenlor Industries, Inc.1989-03-09
DELFIA HLH SPEC KIT (K883814)Pharmacia, Inc.1989-03-08
BIOTROL IRON REAGENT (K890395)Biotrol, USA, Inc.1989-03-08
ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT (K890645)Serono-Baker Diagnostics, Inc.1989-03-08
MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 (K890534)Fisher Scientific Co., LLC1989-03-08
ALLEVYN TRACHEOSTOMY DRESSING (K890748)Smith & Nephew United, Inc.1989-03-08
SHAPE-ACTIO URINALYSIS CONTROLS (K890442)Actio, Inc.1989-03-08
DELFIA SHBG KIT (K884809)Pharmacia, Inc.1989-03-08
STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE (K890669)Norfolk Scientific, Inc.1989-03-08
EURO-MED LIGHT TOUCH BIOPSY PUNCH (K884740)Buckman Co., Inc.1989-03-06
KOSAN ANGEL LATEX SURGICAL GLOVES (STERILE) (K890311)Kosan Far East Ent. , Ltd.1989-03-03
DENTOCULT SM-STRIP MUTANS (K890199)Orion Corp.1989-03-02
WIDEX BTE HEARING AID MODEL Q8 (K885128)Widex Hearing Aid Co., Inc.1989-03-01
ULTIMA WHEELCHAIR CUSHION (K890653)Clark Pillow Co., Inc.1989-02-28
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Every clearance here is in the API, with alerts when new ones post.