FDA 510(k) clearances — page 659
clearances on record, most recent first.
Clearances — page 659
65,801–65,900 of 175,825- K050177 — COLACTIVE COLLAGEN WOUND DRESSING
- K050188 — EPIGUARD
- K050324 — INFPUMP INFILTRATION PUMP
- K050340 — MICROMEDICS SPHENOID SINUS STENT
- K050508 — HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES
- K050537 — LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS
- K050543 — NEXUS DETACHABLE COIL SYSTEM
- K050683 — SYNTHES (USA) 3.5MM CONICAL SCREWS
- K050752 — AESCULAP ORTHOPILOT 2 THA V 2.0
- K050837 — REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE
- K050866 — CENTRION 500 C-ARM SYSTEM
- K050987 — DIGITAL RADIOGRAPHY MODEL CXDI-40EG
- K051013 — SPINEMED S200B/S200C
- K043380 — MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1
- K050157 — MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS
- K050194 — AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
- K050256 — APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
- K050462 — SBI HAND FIXATION SYSTEM (TM)
- K050487 — QUANTIA LA(A)
- K050533 — ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE
- K050544 — HEMOSIL D-DIMER HS
- K050619 — 20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB
- K050625 — VARELISA RECOMBI ANA PROFILE, MODEL 18496
- K050646 — SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
- K050708 — LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-9000
- K050719 — ABX PENTRA DX 120: OPTION SPS EVOLUTION
- K050815 — XACT.CARDIAC & XPRESS.CARDIAC
- K050932 — DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
- K042526 — DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
- K043231 — PROOF POSITIVE ELECTRONIC PREGNANCY TEST
- K043519 — ARIOL HER-2/NEU FISH
- K050387 — ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
- K042116 — STERRAD NX STERILIZER
- K042917 — STAT MEDICAL PEN NEEDLE
- K043143 — SAFEPICO
- K043228 — ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
- K043495 — BABYPAC
- K050423 — OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
- K050578 — COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
- K050617 — 21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB
- K050712 — 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT
- K050762 — PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90
- K050777 — PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
- K050880 — DYRACT EXTRA RESTORATIVE
- K041579 — MEDELA SINGLE USE SILC CUP, MODEL 077.0791
- K043531 — MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
- K050030 — ACTICOAT MOISTURE CONTROL DRESSING
- K050357 — CAMCERAM TCP
- K050404 — INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
- K050560 — EUROCHAIR
- K050576 — MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H
- K050588 — VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM
- K050615 — STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000
- K050616 — 21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB
- K050633 — TRIAL CABLE RETENTION CLIP
- K050636 — SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
- K050691 — R. POON MEDICAL PRODUCTS WHEELCHAIRS
- K050703 — QBRAIN
- K050716 — ISCIENCE SURGICAL VISCOINJECTOR
- K050744 — KAVO ERGOCOM/ERGOCAM
- K050751 — IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X
- K050772 — NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000
- K050792 — LANDLEX, MODEL S300X
- K050810 — AGFA CR50.0
- K050580 — SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
- K050647 — ALL-IN-ONE
- K050723 — MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS
- K050725 — PROTEGE GPS SELF-EXPANDING NITINOL STENT
- K050801 — URISCAN OPTIMA II URINE ANALYZER
- K050895 — SURPASSON P5 NEWTRON
- K042721 — KOLIBRI SPINE
- K050165 — MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100
- K050258 — GROOVY IMPLANTS
- K050695 — FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT
- DEN050001 — DECAPINOL ORAL RINSE
- DEN050003 — PAXGENE BLOOD RNA SYSTEM
- K042449 — DOLPHIN INFLATION DEVICE
- K043083 — ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL
- K043339 — REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG
- K043356 — WAGNER SL REVISION STEM LATERAL
- K043538 — HYPERTRANSIT INFUSION CATHETER
- K050122 — POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)
- K050310 — BARDPORT TITANIUM PORTS
- K050321 — ONTRAK TESTCARD 9
- K050553 — NOVEL VBR SPINAL SYSTEM
- K050707 — LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000
- K050724 — SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM
- K041495 — PENTADEFLUE IV SOLUTION ADMINISTRATION SETS
- K042018 — ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
- K042927 — VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
- K042944 — HOME-AWAY SYSTEM, MODEL 1041
- K042965 — TOMAS PIN
- K043250 — STRYKER PATIENT SPECIFIC POLYMER IMPLANT
- K043328 — MICROFLO-SAFE SCALP VEIN SET
- K043419 — P&P SAFETY SYRINGE
- K043500 — FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE
- K050101 — THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10
- K050153 — SPIRIT, MODEL HAS
- K050254 — SPECTRA-SP CO2 LASER SYSTEM
- K050358 — ARTHERX CORKSCREW FT II SUTURE ANCHOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.