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
45529–45552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 2011
SEASPINE MONOPOLAR PROBE SYSYEM
K111671 · ETN
Seaspine, Inc.
Ear, Nose, Throat · 196d
Cleared CT Dec 28, 2011
DELTAVIEW MODEL 2.1
K111776 · LLZ
Riverain Medical Group,Llc
Radiology · 188d
Cleared Dec 28, 2011
PRESERVE HIP STEM
K112080 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 160d
Cleared Dec 28, 2011
GEISTLICH COMBI-KIT COLLEGEN
K112572 · NPM
Geistlich Pharma AG
Dental · 113d
Cleared Dec 28, 2011
CERAMIR CROWN & BRIDGE
K113040 · EMA
Doxa Dental AB
Dental · 77d
Cleared Dec 28, 2011
NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE,...
K113283 · NHA
Straumann USA
Dental · 51d
Cleared Dec 28, 2011
LIFECHOICE OXYGEN CONCENTRATOR
K113317 · CAW
Inova Labs, Inc.
Anesthesiology · 48d
Cleared Dec 27, 2011
PROCEDURE REHEARSAL STUDIO(TM)
K112387 · LLZ
Simbionix , Ltd.
Radiology · 131d
Cleared Dec 27, 2011
O_TWO CPAP SYSTEM
K112546 · BYE
O-Two Medical Technologies, Inc.
Anesthesiology · 117d
Cleared Dec 27, 2011
GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO
K112575 · NPM
Geistlich Pharma AG
Dental · 112d
Cleared Dec 27, 2011
SLEEPSTRIP II
K112822 · MNR
S.L.P. , Ltd.
Anesthesiology · 90d
Cleared Dec 27, 2011
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM
K112923 · HRS
Suspension Orthopaedic Solutions, LLC
Orthopedic · 85d
Cleared Dec 27, 2011
ACCESS THYROGLOBULIN ANITBODY
K112933 · JNL
Beckman Coulter, Inc.
Immunology · 85d
Cleared Dec 23, 2011
TINA-QUANT HBA1C GEN.2
K110313 · LCP
Roche Diagnostics
Chemistry · 324d
Cleared Dec 23, 2011
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
K110717 · MUE
Konica Minolta Medical & Graphic, Inc.
Radiology · 283d
Cleared Dec 23, 2011
ROCHE ACETAMINOPHEN ASSAY
K110726 · LDP
Roche Diagnostics
Chemistry · 282d
Cleared Dec 23, 2011
1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
K111673 · MOS
Invivo Corporation
Radiology · 191d
Cleared Dec 23, 2011
DR. GREENSBURG'S HYBRID
K111680 · LRK
Always More Marketing, Inc.
Dental · 191d
Cleared Dec 23, 2011
GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT
K112352 · JJX
Bionostics, Inc.
Chemistry · 129d
Cleared Dec 23, 2011
AU5800(R) CHEMISTRY ANALYZER
K112412 · CEM
Beckman Coulter, Inc.
Chemistry · 123d
Cleared Dec 23, 2011
BIOMERIX COMPOSITE SURGICAL MESH
K112499 · FTL
Biomerix Corporation
General & Plastic Surgery · 115d
Cleared Dec 23, 2011
BIOMERIX ASSURE
K112567 · FTL
Biomerix Corporation
General & Plastic Surgery · 112d
Cleared Dec 23, 2011
ZAVATION IBF SYSTEMS
K112664 · ODP
Zavation, LLC
Orthopedic · 101d
Cleared Dec 23, 2011
EASY TOUCH
K112789 · FMI
Mhc Medical Products, LLC
General Hospital · 88d