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
139681–139704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 1987
DIGOXIN FPIA CALIBRATORS
K872328 · DLJ
Sigma Chemical Co.
Chemistry · 20d
Cleared Jul 07, 1987
DIGOXIN FPIA CONTROLS
K872347 · LAS
Sigma Diagnostics, Inc.
Toxicology · 20d
Cleared Jul 06, 1987
MICOR
K865010 · DQK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 195d
Cleared Jul 06, 1987
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
K871388 · LCP
Bio-Rad
Hematology · 90d
Cleared Jul 06, 1987
LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II
K872227 · JJY
Bio-Rad
Chemistry · 27d
Cleared Jul 06, 1987
DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
K872360 · GHH
American Dade
Hematology · 18d
Cleared Jul 02, 1987
PLAK VAK - PV-10
K864540 · EFS
Paul S. Barclay, D.D.S. , Ltd.
Dental · 225d
Cleared Jul 02, 1987
GLUMA(TM) BONDING SYSTEM
K871164 · EBF
Columbus Dental Mfg. Co.
Dental · 100d
Cleared Jul 02, 1987
CLEARFIL PORCELAIN BOND
K871636 · KLE
Kuraray Co.
Dental · 66d
Cleared Jul 02, 1987
SPATULA, DENTAL, CEMENT
K871818 · EJB
Military Engineering, Inc.
Dental · 52d
Cleared Jul 02, 1987
COULTER COUNTER MODEL S-PLUS STKR
K871837 · GKZ
Coulter Electronics, Inc.
Hematology · 51d
Cleared Jul 02, 1987
XOMED PLATINUM WIRE TEFLON PISTION
K872112 · ETB
Xomed, Inc.
Ear, Nose, Throat · 31d
Cleared Jul 02, 1987
ABRASIVE DISC - POLISHING WHEEL
K872251 · EJR
Dentsply Intl.
Dental · 20d
Cleared Jul 02, 1987
PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS
K872272 · EBF
Columbus Dental Mfg. Co.
Dental · 20d
Cleared Jul 02, 1987
SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER
K872279 · EBF
3M Company
Dental · 17d
Cleared Jul 02, 1987
NEEDLE & BLADE COUNTER & DISPOSAL UNIT
K872313 · MMK
Gary Plastic Packaging Corp.
General Hospital · 15d
Cleared Jul 02, 1987
SIDE CUTTING PARALLEL ACTION PLIERS
K872384 · HTC
Med-Tool, Inc.
General & Plastic Surgery · 13d
Cleared Jul 02, 1987
C CLAMP
K872386 · HXD
Med-Tool, Inc.
General & Plastic Surgery · 13d
Cleared Jul 02, 1987
CK 1600 SERIES, TOWELS
K872395 · KKX
Currie Medical Specialties, Inc.
General Hospital · 10d
Cleared Jul 02, 1987
SURGICAL BUR
K872475 · GFF
Tava Surgical Instruments
General & Plastic Surgery · 9d
Cleared Jul 01, 1987
LACEY METAL BACKED PATELLA PROSTHESIS
K870273 · JWH
Dow Corning Wright
Orthopedic · 155d
Cleared Jul 01, 1987
KENZ-CARDICO 1201
K870443 · LOS
Suzuken Co., Ltd.
Cardiovascular · 148d
Cleared Jul 01, 1987
POLYTRON MODELS 1001, 1002 AND 1004
K870821 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 120d
Cleared Jul 01, 1987
WAGNER REVISIONAL FEMORAL HIP PROSTHESIS
K871347 · JDI
Protek, Inc.
Orthopedic · 86d