FDA 510(k) clearances — page 911
clearances on record, most recent first.
Clearances — page 911
91,001–91,100 of 176,637- K973789 — NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC
- K973892 — RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)
- K974015 — ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL
- K974080 — CRITIKON SOFT BLOOD PRESSURE CUFF
- K974534 — MICRO-PLATE COTININE EIA
- K980354 — CRYPTOSPORIDIUM TEST
- K980379 — PROWESS PRO-SIM
- K980584 — ATLASPLAN
- K980609 — SEGMENTAL DEFECT REPLACEMENT SYSTEM
- K980610 — DEXON RAPID (DEXON R)
- K980754 — CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G
- K980773 — ETEST GREPAFLOXACIN
- K980955 — PASCO MIC AND MIC/ID PANELS
- K981001 — ORION VESTA DENTAL ALLOY
- K981002 — ORION WX DENTAL ALLOY
- K981020 — ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
- K981085 — GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
- K981232 — CA
- K981338 — LD-1
- K981347 — SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
- K981348 — SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES
- K981349 — SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES
- K981401 — BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS
- K971077 — COVERTIP SAFETY SYRINGE
- K980014 — THE SYSTEM 2S STEAM STERILIZER
- K980210 — VARIOUS SURGICAL OR PATIENT DRAPES
- K980575 — SITESEER ANGIOGRAPHIC CATHETER
- K980620 — DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM
- K980647 — EYE IRRIGATOR MODEL #2020
- K980732 — 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT
- K980792 — CU-100A LIGHT CURE UNIT
- K980793 — Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT
- K981000 — CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN
- K981073 — MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK
- K981179 — LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES
- K971421 — BARD ISOFLOW BLOOD PUMP
- K973920 — STARDUST
- K974234 — MICRO-PLATE COTININE EIA
- K974584 — FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
- K980935 — CAPIOX SX HARDSHELL RESERVOIR
- K981239 — DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
- K971207 — SOFTLIGHT Q-SWITCHED (ND:YAG) LASER
- K971374 — GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE
- K974008 — PFLEIDERER'S INTRATYMPANIC CATHETER
- K974491 — ACCU-CHEK A1C HEMOGLOBIN TEST
- K980547 — NIDEK PRIMA MODEL GYC-1500/2000
- K980548 — DURA-PATCH MODEL DP-XXX
- K980603 — ETEST TROVAFLOXACIN
- K980649 — PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS
- K981413 — SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
- K981455 — THIRD GENERATION PSA CONTROL MODULE
- K971408 — SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
- K973820 — USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
- K973922 — ARCHIMED 4210 AND 4220
- K974196 — MEGAVAC SYSTEM
- K980076 — PREMIER PLATINUM HPSA
- K980337 — DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
- K980530 — PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13
- K980671 — COLOSCREEN-ES
- K980726 — ULTRA-BLASTER
- K980810 — SERAQUEST ANTI-SSA
- K980811 — SERAQUEST ANTI-SM/RNP
- K980857 — MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
- K980859 — HEMOCOR HPH MINI HEMOCONCENTRATOR
- K981059 — ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.
- K981231 — CO2
- K981256 — ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
- K981425 — STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
- K981426 — STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
- K981427 — STAT PROFILE M ANALYZER
- K981532 — LYPHOCHEK IMMUNOASSAY PLUS CONTROL
- K973561 — MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M
- K973955 — HERNIAMESH SURGICAL MESHES
- K974038 — THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT
- K974560 — CORDIS VANGUARD STEERABLE GUIDEWIRES
- K980021 — EXTENTRAC
- K980065 — C/T MED-SYSTEMS CASSETTE SYSTEM
- K980512 — LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW
- K980595 — DEPUY ORTHOTECH CATERA SUTURE ANCHOR
- K980624 — CARDIOSTATION
- K980645 — PHILIPS GYROSCAN NT RELEASE 6 SERIES
- K980691 — AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K980704 — SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K980741 — BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)
- K980809 — LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
- K980844 — SURGIDEV SILICONE PUNCTUM PLUG
- K980863 — DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)
- K980892 — HAKOMED ELECDT / PRO ELEDT SERIES
- K980928 — SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM
- K980942 — REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE
- K980958 — HAKOMED ELECDT/VACUPULLS
- K980963 — HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)
- K980986 — PROCAD
- K980988 — AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)
- K981128 — SOFSILK SUTURE
- K981259 — OSTEO 4.0MM CANNULATED SCREW SYSTEM
- K981327 — INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
- K981372 — SYNTHES 3.0 MM PC-FIX SYSTEM
- K981392 — ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
- K981516 — STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB
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