FDA 510(k) clearances — page 978
clearances on record, most recent first.
Clearances — page 978
97,701–97,800 of 175,890- K955563 — FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS
- K955713 — NOBELPHARMA BONE ANCHORED HEARING AID
- K961139 — EAGLE PATIENT MONITOR MODEL 3000/3100
- K961467 — HEAD RETAINING DEVICE
- K961791 — DEPUY DISPOSABLE FILTER/HOOD
- K961854 — SPR PLUS II OVERLAY SYSTEM (CL250/CL212
- K961855 — POLAR CARE (MODEL 500/50000)
- K961872 — INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
- K961922 — RDP-2
- K962119 — RE-NEW LAPAROSCOPIC INSTRUMENTS
- K962238 — SELECT SHOULDER KEELED ALL-POLY GLENOIDS
- K962244 — SELECT SHOULDER PEGGED ALL-POLY GLENOID
- K962328 — SINGLE USE INSTRUMENT TRAY
- K962380 — OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200)
- K962530 — PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
- K962533 — OLYPUS FG SERIES GRASPING FORCEPS
- K962600 — REXAM SELF-SEAL TYVEK POUCH
- K962693 — MONTGOMERY RADIOPAQUE LARYNGEAL KEEL
- K962847 — MT10P, MT60-PP, MT60-AGC0, AND MT60
- K954028 — HP SONOS ULTRASOUND IMAGING SYSTEM
- K954769 — BIEGLER BW385L BLOOD & INFUSION WARMER
- K954987 — ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
- K954996 — TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM
- K955270 — TAPE & BANDAGE, ADHESIVE
- K955525 — FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70
- K955916 — TOWNLEY TOTAL ELBOW SYSTEM
- K960625 — SPREADABLE SHEATH INTRODUCER SET
- K960765 — MENTOR ADVENT A/B SYSTEM
- K960908 — SRRS PRESSED FIT FEMORAL REVISION COMPONENT
- K961116 — FIRST BEAT/CARDIO BEAT/CALC
- K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN
- K961288 — BODYTRODE
- K961752 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
- K961902 — SIEMENS BEAM SHAPER
- K961998 — QUALITROL SYPHSERO CONTROL SET
- K962002 — AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
- K962132 — SILKON STAINLESS STEEL CABLE SYSTEM
- K962210 — BACTEC 9050 SYSTEM
- K962346 — PAPILLOTOME
- K962362 — CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS
- K955766 — ADULT-PEDIATRIC TRANSPORT SYSTEM
- K960422 — PRUITT SAFETY OCCLUSION CATHETER
- K960544 — CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM
- K960761 — PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20
- K960976 — KINEMATIC II REPLACEMENT TIBIAL INSERTS
- K961413 — SYNTHES ANATOMICAL LOCKING PLATE SYSTEM
- K961472 — DENTAL DAM SILICONE
- K961858 — COSGROVE DEPTH ELECTRODE KIT(CDEK)
- K961877 — PISTON SYRINGE
- K961918 — MULTI-TEST II
- K962086 — CPS, CEMENTED CUP SYSTEM
- K962333 — V.R.S. DENTURE RESIN MATERIAL
- K962606 — TOPOGRAPHIC IMAGING MARKER
- K952927 — IMPACT AIR 45 4-HOLE
- K955865 — BEAR CUB INFANT PRESSURE VENTILATOR
- K960297 — MANDIBULAR BONE DISTRACTOR II
- K960430 — CONTROL SYRINGE
- K960499 — HEARTRAK XL
- K961214 — MULTI LEAF COLLIMATOR
- K961825 — ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
- K961831 — STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK
- K961874 — STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK
- K961901 — BONE & MARROW COLLECTION SYSTEM
- K961905 — MEDICINELODGE, INC. SET SCREW
- K962071 — SPIRIT S1/S2
- K962456 — SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH
- K962743 — PULPDENT SODIUM HYPOCHLORITE SOLUTION
- K950809 — VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES
- K952244 — CROSS-CHECKS EO GAS STERILIZATION MONITOR
- K954861 — BRAINLAB CT/X-RAY LOCALIZER
- K955849 — DIB INFUSOR
- K955852 — CRYPTO-CEL IF TEST
- K955897 — CRYPTO/GIARDIA-CEL IF TEST
- K960318 — DIB INFUSOR-RA
- K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM
- K960588 — WAGNER REVISION STEM
- K961477 — TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY
- K961571 — COCR BI-ANGULAR HUMERAL COMPONENT
- K961921 — APR OVERSIZED HIP STEM
- K962011 — SYNTHES 7.0/7.3 MM CANNULATED SCREWS
- K962022 — POWERCUT GOLD SURGICAL SYSTEM
- K962367 — OLYMPUS BASKET GRASPERS
- K955760 — TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM
- K960044 — ULTRAMAX/MODEL NUMBER A1
- K960075 — CHROMAGAR CANDIDA
- K961183 — CBI 7520 READER
- K961770 — PHILIPS 71 SERIES
- K961842 — SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM
- K962125 — TECHNICON IMMUNO 1 SYSTEM
- K962137 — GENESIS II CONSTRAINED SYSTEM
- K962352 — HYDROGEL SKIN DRESSING
- K962378 — OLYMPUS FG-45/46-1 GRASPING FORCEPS
- K962399 — HEPATITIS NEGATIVE CONTROL
- K962423 — BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM
- K962480 — COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED
- K955514 — SHARPS SAFE 1.5 & SHARPS SAFE 2.0
- K955534 — SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)
- K960109 — QUANTITATIVE SENTINEL SYSTEM
- K960257 — N ANTISERUM TO C1 INHIBITOR
- K960293 — MRTOFLM COMPUTER PROGRAM
Data sourced from openFDA. This site is unofficial and independent of the FDA.