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
55009–55032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 2008
FUTURABOND M/FUTURABOND M SINGLE DOSE
K082753 · KLE
Voco GmbH
Dental · 66d
Cleared Nov 24, 2008
SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED...
K082807 · HRS
Synthes (Usa)
Orthopedic · 61d
Cleared Nov 24, 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3
K082881 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 56d
Cleared Nov 24, 2008
WU'S 4-WHEELED NEO SCOOTER, WT-M3A
K082963 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 52d
Cleared Nov 24, 2008
PHILIPS INTELLIVUE MP5 PATIENT MONITOR
K083228 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 21d
Cleared Nov 21, 2008
GE LUNAR FEMUR STRENGTH SOFTWARE
K072664 · KGI
Ge Medical Systems Ultrasound and...
Radiology · 428d
Cleared Nov 21, 2008
DIASORIN LIASON RUBELLA IGG ASSAY
K073390 · LFX
DiaSorin, Inc.
Microbiology · 354d
Cleared Nov 21, 2008
STOMA BONE BLOCK SCREW
K080430 · DZL
Storz AM Mark GmbH
Dental · 276d
Cleared Nov 21, 2008
ISOELASTICU
K081025 · KXE
Remi Sciences, Inc.
Orthopedic · 225d
Cleared Nov 21, 2008
TSRH SPINAL SYSTEM
K081080 · NKB
Medtronic Sofamor Danek
Orthopedic · 219d
Cleared Nov 21, 2008
SAPPHIRE PLASMA ARC DENTAL CURING LIGHT
K081287 · EBZ
Den-Mat Holdings, LLC
Dental · 198d
Cleared Nov 21, 2008
TDS ABUTMENT
K081460 · NHA
Pou YU Biotechnology Co., Ltd.
Dental · 182d
Cleared Nov 21, 2008
VERTEBRAL ACCESS SYSTEM BY VIDACARE
K081713 · MOQ
Vidacare Corporation
General & Plastic Surgery · 157d
Cleared Nov 21, 2008
N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE,...
K082125 · LZA
Best Glove, Inc.
General Hospital · 115d
Cleared Nov 21, 2008
JARIT HULKA UTERINE TENACULUM FORCEPS
K082349 · HDC
J. Jamner Surgical Instruments, Inc.
Obstetrics & Gynecology · 98d
Cleared Nov 21, 2008
CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
K082432 · MWP
Bioptics, Inc.
Radiology · 91d
Cleared Nov 21, 2008
NORDICICE SOFTWARE
K082441 · LLZ
Nordicimaginglab AS
Radiology · 88d
Cleared Nov 21, 2008
SYMBIA, VERSION 4.0
K082506 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Nov 21, 2008
FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD
K082508 · DJG
Branan Medical Corporation
Toxicology · 84d
Cleared Nov 21, 2008
REXASTOM ORAL EASE
K082553 · OLR
Rexaderm, Inc.
General & Plastic Surgery · 79d
Cleared Nov 21, 2008
VIZTEK DR, MODELS: DR1000, DR3000, DR4000
K082604 · KPR
Viztek, Inc.
Radiology · 74d
Cleared Nov 21, 2008
NEORAY DR 2520 DIGITAL IMAGING SYSTEM
K083048 · IZL
Portavision Medical, LLC
Radiology · 38d
Cleared Nov 21, 2008
NEURON SELECT CATHETER SIZE 070
K083125 · DQY
Penumbra, Inc.
Cardiovascular · 30d
Cleared Nov 21, 2008
ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
K083146 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 29d