Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
56353–56376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2008
SMITH & NEPHEW CDS SYSTEM
K081491 · JAA
Smith & Nephew, Inc.
Radiology · 22d
Cleared Jun 19, 2008
TUTOPATCH, TUTOMESH
K081538 · FTM
Rti Biologics, Inc.
General & Plastic Surgery · 17d
Cleared Jun 19, 2008
BEAMER ARGON SNARE PROBE
K081580 · GEI
Conmed Corporation
General & Plastic Surgery · 14d
Cleared Jun 19, 2008
DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
K081584 · FRO
Derma Sciences, Inc.
General & Plastic Surgery · 14d
Cleared Jun 19, 2008
YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R,...
K081590 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 13d
Cleared Jun 18, 2008
VACUETTE PREMIUM SAFETY NEEDLE SYSTEM
K072602 · FMI
Medpro Safety Products, Inc.
General Hospital · 278d
Cleared Jun 18, 2008
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT,...
K080580 · EGJ
Axelgaard Mfg. Co., Ltd.
Physical Medicine · 107d
Cleared Jun 18, 2008
OCCLUSION BALLOON CATHETER, MODEL VENOS
K081052 · DYG
Oscor, Inc.
Cardiovascular · 65d
Cleared Jun 18, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING...
K081106 · HRS
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Jun 18, 2008
ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL...
K081198 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Jun 18, 2008
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE...
K081322 · MOS
Shanghai Chenguang Medical...
Radiology · 37d
Cleared Jun 18, 2008
PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201
K081340 · MOS
Shanghai Chenguang Medical...
Radiology · 36d
Cleared Jun 18, 2008
BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH...
K081392 · HWC
Bioretec, Ltd.
Orthopedic · 30d
Cleared Jun 18, 2008
LUXTEC MLX LIGHT SOURCE
K081477 · FCW
Integra Luxtec, Inc.
Gastroenterology & Urology · 22d
Cleared Jun 17, 2008
ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
K072560 · NAD
Teikoku Pharma USA, Inc.
General & Plastic Surgery · 280d
Cleared Jun 17, 2008
THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
K080034 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 162d
Cleared Jun 17, 2008
MEDRAD INTEGO PET INFUSION SYSTEM
K080297 · FRN
Medrad, Inc.
Radiology · 134d
Cleared Jun 17, 2008
KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT
K080523 · NST
Kronus Market Development Associates,...
Immunology · 112d
Cleared Jun 17, 2008
E-POLY TIBIAL BEARINGS
K080528 · JWH
Biomet Orthopedics, Inc.
Orthopedic · 112d
Cleared Jun 17, 2008
ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)
K080615 · MAX
Titan Spine, LLC
Orthopedic · 105d
Cleared Jun 17, 2008
ASCENSION PYROCARBON LUNATE
K080997 · KWN
Ascension Orthopedics, Inc.
Orthopedic · 70d
Cleared Jun 17, 2008
INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL
K081057 · KNW
Intact Medical Corporation
Gastroenterology & Urology · 64d
Cleared Jun 17, 2008
DC NEURO
K081262 · LLZ
Invivo Corporation
Radiology · 43d
Cleared Jun 17, 2008
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS
K081324 · GEX
Candela Corp.
General & Plastic Surgery · 36d