FDA 510(k) clearances — page 871
clearances on record, most recent first.
Clearances — page 871
87,001–87,100 of 175,890- K984227 — OMEGA II MODULAR TOTAL HIP SYSTEM
- K984526 — ACUSEAL CARDIOVASCULAR PATCH
- K990302 — IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
- K990544 — TRX-CG POWER TILT AND RECLINE SYSTEM
- K990984 — VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS
- K981191 — ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65
- K981668 — SMARTVENT 201 PORTABLE VENTILATOR
- K983919 — EMS MOUTH TO MASK RESUSCITATORS
- K990262 — CLEARPLAN EASY HOME PREGNANCY TEST
- K990587 — ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
- K990888 — MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752
- K990970 — SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS
- K982029 — SHARPS COLLECTION CONTAINER - SAF-T-SHELL
- K982640 — MEDEX 3000 SERIES SYRINGE INFUSION PUMP
- K990737 — 'ECURLINE UMBILICAL CORD CLAMP #3500
- K990817 — IPS D.SIGN PORCELAIN
- K990863 — MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
- K990886 — IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
- K990898 — PRODIGY 4
- K981036 — SMARTBOND
- K990491 — ANGIO-CT MIYABI
- K990567 — GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH
- K990064 — DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
- K990091 — S.P.A.R STERILE AMBULATORY RESERVOIR
- K980745 — SECOND WIND AIR PURIFIER
- K981535 — FOCUS PILOT CONTOURING WORKSTATION
- K982505 — ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE
- K982708 — SPQ TEST SYSTEM
- K983022 — SMARTCELL PROCESSING SYSTEM
- K983115 — TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20
- K983337 — ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068
- K983343 — PLATO BRACHYTHERAPHY, MODEL V. 14.0
- K983467 — THERAPEP
- K983997 — STERICHEK TOTAL CHLORINE TEST KIT
- K984422 — STERILE BACK SURGICAL GOWN WITH HAND TOWEL
- K984513 — TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K990004 — DCI ENDOSCOPE
- K990314 — MULTI-CURE COMPOSITE CEMENT
- K990495 — POWDER FREE NITRILE EXAMINATION GLOVES
- K990499 — PREPOWDERED NITRILE EXAMINATION GLOVES
- K990501 — POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM
- K990502 — PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
- K990670 — HELIOFORM GOLD-BASED ALLOY
- K990726 — ENVY GUIDING CATHETER
- K990749 — SOF-SUCTION FLUID EVACUATION SYSTEM
- K990790 — VISION PORCELAIN
- K982696 — INTERPLANT
- K983524 — LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)
- K984355 — POINT SETTER
- K990002 — QUICKRAY DSX 730
- K990007 — OPART, MODEL MRT-600
- K990028 — ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
- K990174 — ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV
- K990185 — MDILOG, MODEL MDC-512
- K990188 — INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1
- K990256 — CRX WORLD SHUNT
- K990307 — OMNI-FIX, NAIL SYSTEM
- K990322 — PERRY HUMERAL NAIL
- K990352 — COULTER AC T DIFF 2 ANALYZER
- K990951 — MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE
- K990952 — NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
- K990086 — HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
- K990220 — MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
- K990251 — DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
- K990264 — COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS
- K990311 — VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER
- K990354 — ENDOSHEATH
- K990424 — ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
- K990436 — ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM
- K990516 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
- K990601 — BOJRAB MICRO-TORP, MODEL 7014-5845
- K990664 — PRIMA SYSTEM - OLD, BARTELS ELISA - NEW
- K990923 — TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010
- K982660 — ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
- K990062 — SAPHLIFT
- K990075 — LPULSA SYL-9000 OPHTHALMIC YAG LASER
- K990278 — DAUM NEUROCUT NEUROBIOPSYNEEDLE
- K990608 — ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05
- K990703 — SPOROX II STERILIZING & DISINFECTING SOLUTION
- K990708 — TITANIUM VERSALOK
- K990745 — MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
- K990851 — INDIGO LASEROPTIC TREATMENT SYSTEM
- K990855 — COOPERSURGICAL INFRARED COAGULATOR FOR ENT
- K990860 — VIEWPOINT MICROSCOPE OPTION
- K990868 — VIEWPOINT PASSIVE TOOL OPTION
- K982641 — ADVANCED NIBP MODULE
- K983225 — BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER
- K983496 — RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T
- K984039 — CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS)
- K984611 — DRAGER SOLA SERIES, MODELS 1000/700/500/300
- K984641 — FLEXISCOPE OPTOMODUL
- K990210 — POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP
- K990267 — POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES
- K990299 — POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES
- K990388 — TUTOPLUS IV ADMINISTRATION SET
- K990415 — LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED)
- K990420 — LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
- K982278 — MICRINS MICRO ANASTOMOSIS CLAMP
- K982414 — GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
- K984591 — DORNIER MEDILAS H/2
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