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
54577–54600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 2009
BIOLAND BLOOD PRESSURE MONITOR
K083681 · DXN
Bioland Technology, Ltd.
Cardiovascular · 35d
Cleared Jan 15, 2009
MIROXI
K081033 · DQA
Mir Medical Intl. Research Srl
Anesthesiology · 279d
Cleared Jan 15, 2009
GISH ARTERIAL FILTER WITH HA COATING
K081054 · DTM
Gish Biomedical, Inc.
Cardiovascular · 276d
Cleared Jan 15, 2009
NUVASIVE SURGICAL MESH SYSTEM
K081377 · FTL
Nuvasive, Inc.
General & Plastic Surgery · 244d
Cleared Jan 15, 2009
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
K081911 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 196d
Cleared Jan 15, 2009
PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT
K082115 · EMA
S & C Polymer GmbH
Dental · 171d
Cleared Jan 15, 2009
MINNIE SUPPORT CATHETER
K082337 · DQY
Vascular Solutions, Inc.
Cardiovascular · 154d
Cleared Jan 15, 2009
TRAUSON GENERAL SPINAL SYSTEM (GSS)
K082617 · MNI
Trauson (Jiangsu) Medical Instrument...
Orthopedic · 128d
Cleared Jan 15, 2009
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98,...
K082716 · EFB
A-Dec, Inc.
Dental · 120d
Cleared Jan 15, 2009
ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505
K082955 · GEI
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 104d
Cleared Jan 15, 2009
BIOLOX DELTA OPTION CERAMIC HEADS
K082996 · LZO
Biomet, Inc.
Orthopedic · 99d
Cleared Jan 15, 2009
G-FORCE TENODESIS SCREW
K083150 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 83d
Cleared Jan 15, 2009
REAL-TIME PCR INTERNAL CONTROL 2B SET
K083430 · OLD
Nanogen, Inc.
Microbiology · 57d
Cleared Jan 15, 2009
MODIFICATION TO: METHA HIP SYSTEM
K083495 · LZO
Aesculap Implant Systems, Inc.
Orthopedic · 51d
Cleared Jan 15, 2009
MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
K083537 · NEY
Medwaves Incorporated
General & Plastic Surgery · 48d
Cleared Jan 15, 2009
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K083839 · OTP
C.R. Bard, Inc.
Obstetrics & Gynecology · 23d
Cleared Jan 15, 2009
IMNS MEDACTA NAVIGATION SYSTEM
K083872 · OLO
Medacta International S.A.
Orthopedic · 17d
Cleared Jan 15, 2009
LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
K090004 · DWA
Levitronix, LLC
Cardiovascular · 13d
Cleared Jan 14, 2009
FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
K080964 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 285d
Cleared Jan 14, 2009
GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
K081064 · MHI
Ivd Research, Inc.
Microbiology · 275d
Cleared Jan 14, 2009
SPECTRA-SYSTEM ABUTMENTS 2008
K081101 · NHA
Implant Direct, LLC
Dental · 272d
Cleared Jan 14, 2009
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
K081378 · DJR
Thermo Fisher Scientific
Toxicology · 243d
Cleared Jan 14, 2009
SWISSPLANT DENTAL IMPLANT SYSTEM
K081396 · NHA
Implant Direct, LLC
Dental · 240d
Cleared Jan 14, 2009
EXPANDABLE PEEK-OPTIMA IMPLANT
K082406 · MAX
Ebi, L.P.
Orthopedic · 146d