FDA 510(k) clearances — page 836
clearances on record, most recent first.
Clearances — page 836
83,501–83,600 of 175,890- K993191 — TFX MEDICAL INTRODUCER ASSEMBLY
- K993194 — RUSCH MANUAL RESUSCITATOR BAG
- K994230 — ULTICARE DISPOSABLE SYRINGE
- K994370 — ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
- K994373 — HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4)
- K994376 — FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA
- K000269 — BELLEGLASS HP OPACEOUS DENTIN
- K000288 — REICHERT CT200 CONTACT TONOMETER
- K000306 — PINNACLE ACETABULAR SYSTEM
- K000564 — CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
- K000616 — SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828
- K983826 — 3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
- K992174 — PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
- K993292 — BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER
- K993303 — SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
- K993757 — SOLAR 7/8000
- K993826 — NARKOMED 6000
- K994011 — EP MEDSYSTEMS, EP-WORKMATE
- K994431 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES
- K994226 — STERICHEK TOTAL CHLORINE REAGENT STRIPS
- K994339 — HYCURE ORAL / HYCURE ORAL SMART GEL
- K994351 — M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
- K994352 — SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896
- K994353 — SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
- K994355 — RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION
- K000038 — INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED
- K000039 — INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED
- K000040 — INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED
- K000203 — HARDYDISK, KANAMYCIN, 30MCG
- K000229 — VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE
- K000239 — GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
- K000258 — HARDYDISK, CIPROFLOXACIN, 5MCG
- K000259 — HARDYDISK, CEFTAZIDIME, 30MCG
- K000376 — SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT
- K000529 — LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED)
- K000576 — ELECSYS CORTISOL CALCHECK
- K000728 — MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
- K992703 — CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
- K993953 — OVES CERVICAL CAP
- K994311 — MALE LATEX CONDOM WITH VANILLA FLAVOR
- K994312 — MALE LATEX CONDOM 56MM
- K994317 — I-PLANT, MODEL 3500
- K994344 — NEUROTHERM RF CANNULA
- K994359 — BOND 1 C & B
- K000057 — RADIONICS LUMBOPERITONEAL SHUNT
- K000103 — AVL OPTI R ANALYZER
- K000439 — DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C
- K000488 — VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB
- K000635 — MODIFICATION TO HP M2376A DEVICE LINK SYSTEM
- K000716 — ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
- K991840 — FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER
- K992180 — VISAGE COSMETIC SURGERY, MODEL V5000
- K992530 — BIPAP SYNCHRONY HC
- K993225 — BLADEWORKS MICROKERATOME BLADE
- K993343 — ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS
- K993357 — IOLMASTER
- K993733 — LOVE LOCKERS
- K993735 — DOUBLE SPRINGERS
- K993737 — MIGHTY MAN (DYNAMIC LINKERS)
- K994290 — BARD ENDOSCOPIC SUTURING SYSTEM
- K994306 — REVERSO
- K994319 — MODULAP
- K994335 — PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS
- K000042 — ELECSYS B-CROSSLAPS CALCHECK
- K000077 — STERIS AMSCO MILLENNIUM STEAM STERILIZER
- K000085 — PORTSETT
- K000087 — MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
- K000211 — BUILD-IT FR
- K000286 — BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
- K000287 — BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
- K000312 — VARELISA SM ANTIBODIES
- K000359 — EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO
- K000417 — CONVERTORS EQUIPMENT DRAPES
- K000501 — ELECTROSURGICAL GENERATOR, MODEL S1
- K000550 — OTW MEGALINK SDS BILIARY STENT SYSTEM
- K000583 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
- K000644 — SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
- K992481 — CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
- K992513 — THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
- K993609 — SOLOGUARD LOCKING PLUS SYRINGE
- K994119 — SYNOCTA ANGLED ABUTMENTS
- K994257 — LOCATOR IMPLANT ANCHOR
- K994280 — ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105
- K994309 — SOLO ORTHO 2
- K994367 — UMBILICAL CORD CLAMP
- K000551 — IMAGE X-70 PLUS DENTAL X-RAY UNIT
- K000695 — GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
- K990504 — MEMOTHERM COLORECTAL STENT
- K991881 — 125-IMPLANT SEEDS, MODEL STM1250
- K993122 — MSP M/K BLADE
- K994267 — FRESENIUS 2008K
- K994287 — FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER
- K994366 — TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
- K994385 — BABY FACE
- K994387 — RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL
- K000045 — POSITUBE
- K000053 — ACL 9000 SYSTEM
- K000066 — SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
- K000086 — WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
- K000536 — SYNTHES ANTERIOR CSLP SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.