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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
51193–51216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2010
COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202,...
K091363 · CAH
Ag Industries
General Hospital · 272d
Cleared Feb 04, 2010
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
K091522 · MST
Immco Diagnostics, Inc.
Immunology · 258d
Cleared Feb 04, 2010
NEXUS INJECTION SITE, MODEL NIS-8
K092527 · FPA
Nexus Medical, LLC
General Hospital · 170d
Cleared Feb 04, 2010
SPINE360 ANTERIOR CERVICAL PLATE SYSTEM
K092531 · KWQ
Spine360
Orthopedic · 170d
Cleared Feb 04, 2010
ESL SPINAL SYSTEM
K092574 · MAX
Ebi, L.P.
Orthopedic · 167d
Cleared Feb 04, 2010
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS...
K092649 · NBC
Roche Diagnostics Corp.
Chemistry · 160d
Cleared Feb 04, 2010
ANTI-WRINKLE (AGING) LIGHT, MODEL AAL
K092800 · ONE
Led Intellectual Properties, LLC
General & Plastic Surgery · 146d
Cleared Feb 04, 2010
OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL...
K092836 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 142d
Cleared Feb 04, 2010
PARI VIOS
K092918 · CAF
Pari Respiratory Equipment, Inc.
Anesthesiology · 135d
Cleared Feb 04, 2010
SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
K093059 · EBC
Classone Orthodontics, Inc.
Dental · 127d
Cleared Feb 04, 2010
VERTOS MEDICAL MILD DEVICE KIT
K093062 · HRX
X-Sten Corp.
Orthopedic · 127d
Cleared Feb 04, 2010
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
K093142 · HCG
Boston Scientific Corp
Neurology · 122d
Cleared Feb 04, 2010
EXAPACS
K093444 · LLZ
Medincom Technology Corp
Radiology · 91d
Cleared Feb 04, 2010
CANON, MODEL URS-50RF
K093688 · OWB
Virtual Imaging, Inc.
Radiology · 66d
Cleared Feb 04, 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
K093846 · LZO
Zimmer, Inc.
Orthopedic · 51d
Cleared Feb 04, 2010
6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE...
K093927 · LJS
C.R. Bard, Inc.
General Hospital · 44d
Cleared Feb 04, 2010
FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY
K100044 · NKB
Blackstone
Orthopedic · 27d
Cleared Feb 04, 2010
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K100070 · KWQ
Depuy Spine, Inc.
Orthopedic · 24d
Cleared Feb 04, 2010
STRONG DENTAL HANDPIECES
K100192 · EGS
Saeshin Precision Co., Ltd.
Dental · 13d
Cleared Feb 03, 2010
VECTRA PLUS LASER SYSTEM AND ACCESSORIES
K082230 · GEX
Xintec Corporation
General & Plastic Surgery · 545d
Cleared Feb 03, 2010
AMPHETAMINES II
K083764 · DKZ
Roche Diagnostics Corp.
Chemistry · 412d
Cleared Feb 03, 2010
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML
K092491 · NZW
Medefil, Inc.
General Hospital · 174d
Cleared Feb 03, 2010
MICRONJET 600
K092746 · FMI
Nanopass Technologies , Ltd.
General Hospital · 148d
Cleared Feb 03, 2010
NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT...
K093496 · LYY
Oon Corp. Resources
General Hospital · 85d