FDA 510(k) clearances — page 833
clearances on record, most recent first.
Clearances — page 833
83,201–83,300 of 175,890- K000962 — PICO SMOKERLYZER, MODEL EC-50
- K001102 — PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
- K992732 — STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
- K993356 — COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
- K994174 — FRIALIT-2 MH-2 ABUTMENT
- K000205 — EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
- K000222 — UM-L25
- K000340 — HYSTALOG HSG CATHETER
- K000408 — LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
- K000455 — GETTIG GUARD
- K000474 — VIEW NT
- K000478 — THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1
- K000516 — GE LOGIQ 700
- K000936 — VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM
- K000961 — AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE
- K001025 — LIFECARD CF COMPACT RECORDER
- K991380 — OIL FOR TISSUE CULTURE
- K992294 — BIOCERAMIC ORBITAL IMPLANT
- K993268 — MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT
- K000106 — DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
- K000163 — PM 2002 PROLINE/AEC
- K000245 — CSM STRETTA SYSTEM
- K000400 — SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST
- K000402 — SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
- K000487 — MEDTRADE PRODUCTS ALGINATE ISLAND
- K000508 — THERMOFLEX SYSTEM
- K000522 — SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST
- K000571 — GE LOGIQ 700
- K000865 — QUIK-CAP
- K000874 — URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
- K000876 — SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP
- K000945 — PARA 12 PLUS RETICS
- K000991 — MODIFICATION TO TSRH SPINAL SYSTEM
- K001154 — I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
- K994308 — NUVASIVE TOWNLEY FACET SCREW
- K000043 — DRG AURICA ELISA TESTOSTERONE KIT
- K000137 — ENHANCED COMPENSATING FILTER
- K000224 — FLUROPERM 60-OK, PARAGON HDS-OK
- K000398 — SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
- K000406 — RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE
- K000458 — URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
- K000603 — SPIFE CHOLESTEROL PROFILE KIT
- K000895 — STAT PROFILE PHOX PLUS ANALYZER
- K990034 — WILSON-COOK COLONIC Z-STENT
- K991755 — MEDLINE TENDER WET WOUND DRESSING
- K991818 — ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
- K991908 — IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
- K993677 — MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT
- K994289 — SUTUREGROOVE
- K000126 — MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA
- K000223 — NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
- K000238 — HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
- K000241 — RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR
- K000290 — LAZERSMILE, LAZERWHITE
- K000346 — EZ CONNECT
- K000366 — FIXATION STYLETS, MODELS 335-287 AND 335-288
- K000373 — 939UDX URINE PATHOLOGY SYSTEM
- K000411 — CHILI VIDEO, CHILI VIDEOPRO
- K000437 — INTERVENTIONAL BODY COIL
- K000460 — URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
- K000464 — URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
- K000467 — URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
- K000486 — ABC CERVICAL PLATING SYSTEM
- K000494 — SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
- K000558 — SYNTHES (USA) WRIST FUSION PLATES (WFP)
- K000826 — PRODIGY LATERAL VIEW SOFTWARE
- K000864 — INTRASTENT DOUBLESTRUT XS STENT
- K000898 — EEG WITH VIDEO, MODEL EX-NW
- K000911 — MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057
- K000971 — PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
- K001033 — AGILITY STEERABLE GUIDEWIRE
- K001037 — MODIFICATION TO EBI SPINELINK SYSTEM
- K991519 — AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
- K993092 — SONADA ULTRASOUND SYSTEM
- K993489 — CRYSTAL CUSTOM TINTED SOFT CONTACT LENS
- K993503 — HAIDER-UCR SPINAL SYSTEM
- K993545 — TENAX WHITE POST
- K993787 — APPRAISE-CARDIO SAMPLE COLLECTION KIT
- K000112 — ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
- K000117 — AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
- K000147 — CTC DVT-1 CALF GARMENT, MODEL DVT-1
- K000168 — CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
- K000199 — CORTEK MINI LAPAROSCOPE
- K000206 — PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
- K000526 — HARDYDISK, CEPHALOTHIN 30MCG
- K000570 — BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA
- K000646 — DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
- K000661 — RANDOX PREALBUMIN
- K000810 — QUALITROL LIPID CONTROL, LEVELS 1 AND 2
- K000824 — PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
- K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC
- K992664 — TFX MEDICAL STYLET CATHETER
- K992942 — LEMAITRE OCCLUSION CATHETER
- K993608 — DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)
- K993695 — LIGA-LOOP SUTURE APPLICATOR
- K994027 — ACTIVATOR PASTE
- K994164 — ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
- K994221 — BAYER PSA ASSAY
- K994240 — EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133
- K000097 — GSI 2000 MIDDLE EAR ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.