FDA 510(k) clearances — page 562
clearances on record, most recent first.
Clearances — page 562
56,101–56,200 of 176,542- K081913 — METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER
- K081961 — 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER
- K082144 — AMICAS PACS, VERSION 6.0
- K082216 — TBD ETHICON MESH
- K082383 — FORTOSS VITAL
- K082426 — RENASYS EZ
- K070250 — NUTRITONE FACIAL BEAUTY SYSTEM
- K070488 — MICARDIA ANNULOPLASTY BAND DR
- K080089 — SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
- K080412 — ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)
- K080992 — AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
- K081601 — VEO MULTIGAS MONITOR FOR POCKET PC
- K082206 — BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES
- K082235 — BLACKSTONE PILLAR XL PEEK SPACERS
- K073317 — STARLIGHT, MODEL PD9012
- K073478 — SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
- K080094 — OLYMPUS TOTAL BHCG TEST SYSTEN
- K080473 — EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED
- K080594 — MS SYSTEM (NARROW RIDGE)
- K080795 — ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN
- K081042 — MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES
- K081588 — RE-ZORB PLATING SYSTEM
- K081758 — HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015
- K081907 — NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)
- K082042 — GONGDONG DISPOSABLE SHARP CONTAINER
- K082141 — ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10
- K082195 — MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
- K080375 — RMX PHYSIOLOGICAL DATA RECORDER
- K080420 — RESERT XL HLD HIGH LEVEL DISINFECTANT
- K080711 — 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
- K081116 — G-IVF G5 SERIES
- K081568 — ANTEGRA-T
- K081575 — HU/HS/HG PROSTHETIC SYSTEM
- K081821 — D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)
- K081925 — SNAPSHOT
- K082022 — OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++
- K082077 — BT3/6, BT12
- K082104 — GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM
- K082374 — VIVID I AND VIVID Q
- K072213 — PERIMETRICS PERIOMETER
- K073685 — OTA COLLAGEN BIOMATERIAL
- K080529 — STEREOS WORKSTATION
- K080546 — NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
- K081141 — COMBOCARE 2000
- K081432 — HEALOS II BONE GRAFT SUBSTITUTE
- K081610 — SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER
- K081622 — UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
- K081699 — PLANMECA SOVEREIGN
- K081731 — DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
- K081844 — GE DATEX-OHMEDA AVANCE
- K081887 — LUTE-IT II VENEER CEMENT, MODEL NO6
- K081891 — FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR
- K081934 — EXTREMITY MEDICAL COMPRESSION SCREW
- K081937 — PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE
- K082122 — MLCI2
- K082186 — MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM
- K082239 — DEPUY C-STEM AMT
- K082341 — DSA 2000EX
- K082373 — NORAS MR-BI320-PA 3T
- K071023 — REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C
- K073197 — SILVER ANTIMICROBIAL WOUND GEL
- K080405 — SYGNAL DBM
- K080448 — CENTURION PROTECTIVE RESTRAINT, SCR SERIES
- K080873 — OPACITY + BONE CEMENT
- K081361 — CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX
- K081464 — STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES
- K081488 — POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
- K081550 — BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO
- K081559 — GENESIS
- K081606 — BAHA INTENSO
- K081652 — CLAROS NANO DENTAL LASER SYSTEM
- K081691 — INOMAX DS (DELIVERY SYSTEM)
- K081849 — BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
- K082132 — BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
- K082194 — LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002
- K082306 — POWERLOC CLEAR SAFETY INFUSION SET
- K082323 — ARTHROCARE ARTHROWANDS
- K082356 — GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
- K073158 — SCULPTURE 2.94 ER:YAG SYSTEM
- K080554 — INAREX, MODEL 2D-LX
- K080861 — MICRUS ASCENT OCCLUSION BALLOON CATHETER
- K081275 — BOSTON SCIENTIFIC SURGICAL MESH
- K081508 — HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN
- K081762 — CURBELL PATIENT MONITORING CABLES
- K082112 — T2 XVBR SPINAL SYSTEM
- K082127 — STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635
- K082304 — ROLL-X GUIDEWIRE
- DEN080007 — ALLOMAP MOLECULAR EXPRESSION TESTING
- K073633 — STRYKER ESSX MICRODEBRIDER SYSTEM
- K081180 — SKINSENSE POLYISOPRENE UNDERGLOVE
- K081215 — VOLUMINA
- K081511 — 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S
- K081516 — MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
- K081546 — SMALL BONE LOCKING PLATING SYSTEM
- K081708 — TAXI ENDOSCOPIC GUIDEWIRE
- K081726 — TYSONBIO LINK HEALTH MANAGEMENT SYSTEM
- K081903 — XIOS PLUS WALL-MODULE
- K082173 — Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
- K071961 — MESACUP MODELS BP180 AND BP230 ELISA KITS
- K080040 — ORTHO ALL-FLEX DIAPHRAGM
Data sourced from openFDA. This site is unofficial and independent of the FDA.