FDA 510(k) clearances — page 684
clearances on record, most recent first.
Clearances — page 684
68,301–68,400 of 175,825- K041544 — COOK SIDEARM CORE TISSUE BIOPSY DEVICE
- K041583 — PEEK CEMENT RESTRICTOR X-BOX
- K041646 — THERMOTEK Q5
- K041671 — IMAGENMD
- K041701 — AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM
- K041713 — SUPER REVO HERCULINE SUTURE ANCHOR
- K041716 — PTFE FELTS AND PLEDGETS
- K041719 — ONCENTRA-VISIR
- K041759 — ACE CONNECT INTERNAL CONNECTION
- K041807 — LUNG CAR 1.1
- K041819 — GOODKNIGHT 425, MODELM-114500-00
- K041938 — MAXIMUS OS (OVERDENTURE SYSTEM)
- K041112 — MAGNETOM ESPREE SYSTEM
- K041286 — DYNACAD V1.0
- K041411 — MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP
- K041423 — VIABIL BILIARY ENDOPROSTHESIS
- K041474 — MAXCEM
- K041568 — EOCD
- K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY
- K041741 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN
- K040400 — MYO-TRODE SG DISPOSABLE ELECTRODE
- K040465 — LATIT FLOW
- K040897 — DOVER ROB-NEL CATHETER
- K041039 — FERTELL MALE FERTILITY TEST
- K041109 — ZIMMER ANATOMIC II HIP PROSTHESIS
- K041327 — MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES
- K041336 — PRO WALKER PL-200 POWER WHEELCHAIR
- K041376 — C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A
- K041417 — DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423
- K041814 — FS SERIES WHEELCHAIR
- K033897 — MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM
- K040010 — GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS
- K041119 — EXPEDIUM SPINE SYSTEM
- K041174 — CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
- K041317 — MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
- K041318 — MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
- K041324 — CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER
- K041338 — MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
- K041481 — MODEL BBC-127 BIOPSY BREAST COIL
- K041674 — THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT
- K041794 — C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM
- K041816 — RTX3320PSTN WIRELESS TELEHEALTH GATEWAY
- K031395 — MERLIN RESUSCITATOR
- K040466 — BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS
- K040554 — ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256
- K040851 — MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
- K040896 — MODIFICATION TO ENCOMPASS
- K041042 — SPLIT SEPTUM INJECTION SITES
- K041111 — MAGNETOM C! MR SYSTEM
- K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725)
- K041344 — OPEN BORE SYRINGE
- K041354 — VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
- K041564 — Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
- K041575 — FENZIAN TREATMENT SYSTEM
- K041607 — QUINTON Q-TE; RMS
- K041620 — NEURA WRAP NERVE PROTECTOR
- K041624 — PTCA STEERABLE HYDROPHILIC GUIDEWIRE
- K041649 — SAPPHIRE NXT DETACHABLE COIL SYSTEM
- K041702 — EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)
- K041793 — OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
- K040649 — KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE
- K041084 — CLIP-ON SPACER 20%; 40%; 50%
- K041148 — POCONE INFRARED SPECTROPHOTOMETER
- K041225 — SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED
- K041362 — RESMED HOSPITAL FULL FACE MASK
- K041473 — VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
- K041745 — VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
- K041773 — OXYGEN MEDICELS, CITICELS
- K041789 — NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T
- K040678 — EUSURE BLOOD GLUCOSE MONITORING SYSTEM
- K040756 — THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
- K040980 — ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T
- K041014 — TSH-CTK-3 IRMA
- K041753 — AESKULISA ENA 6 S
- K031431 — BAWMED RESCUE MASK
- K033105 — CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT
- K033106 — CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT
- K040231 — INTELIPORT OCCLUDING DEVICE
- K040382 — CRANEX BASEX D OR CRANEX EXCEL D
- K040782 — N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX
- K041221 — ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY
- K041348 — PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
- K041737 — 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)
- K041761 — RAPIDIACOLON
- K041763 — SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES
- K033448 — ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER
- K033739 — PHYSICIAN INDUSTRIES' DURAMETER SYRINGE
- K033858 — TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE
- K040362 — DIAPHARMA FACTOR X KIT
- K041153 — SHARPSAWAY II LOCKING DISPOSABLE CUP
- K041413 — XPS 3000 SYSTEM
- K041574 — CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
- K040266 — CORE NEEDLE BIOPSY
- K040281 — LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)
- K040999 — TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
- K041293 — BIOPORE BALLOON DILATION CATHETER
- K041321 — VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM
- K041391 — FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
- K041454 — KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
- K041586 — PROFEMUR S HIP STEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.