FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
74977–75000 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 2002
ENDOSSOUS IMPLANTS
K021322 · DZE
Intra-Lock International
Dental · 90d
Cleared Jul 24, 2002
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
K021376 · DSI
Datex-Ohmeda
Cardiovascular · 84d
Cleared Jul 24, 2002
SYNTHES IN-SITU BENDER/CUTTER
K021458 · HRS
Synthes (Usa)
Orthopedic · 78d
Cleared Jul 24, 2002
CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
K021466 · LPH
Hayes Medical, Inc.
Orthopedic · 78d
Cleared Jul 24, 2002
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
K021499 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 76d
Cleared Jul 24, 2002
ABP FOR WINDOWS
K021517 · DSK
Rozinn Electronics, Inc.
Cardiovascular · 75d
Cleared Jul 24, 2002
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
K021705 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 62d
Cleared Jul 24, 2002
PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE...
K021784 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 55d
Cleared Jul 24, 2002
HEARTLINE RECEIVING STATION
K022073 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 28d
Cleared Jul 24, 2002
MPF ACETABULAR CUP GENERATION 2
K022120 · LZO
Plus Orthopedics
Orthopedic · 23d
Cleared Jul 24, 2002
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K022190 · MNI
Depuyacromed
Orthopedic · 19d
Cleared Jul 23, 2002
CRIT-LINE MONITOR III TQA (CLM TQA)
K011741 · FIL
Hemametrics
Gastroenterology & Urology · 413d
Cleared Jul 23, 2002
INFINITY MICRO2+
K012770 · DQA
Siemens Medical Solutions USA, Inc.
Anesthesiology · 340d
Cleared Jul 23, 2002
PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007
K012974 · FLL
Prizm Medical, Inc.
General Hospital · 321d
Cleared Jul 23, 2002
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K020356 · MNH
Alphatec Mfg., Inc.
Orthopedic · 169d
Cleared Jul 23, 2002
MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95
K020474 · MSH
Makrite Industries, Inc.
General Hospital · 161d
Cleared Jul 23, 2002
'RAPIDTEC' 5A MULTIPLE DIP TEST
K021114 · DKZ
American Bio Medica Corp.
Toxicology · 109d
Cleared Jul 23, 2002
PROLITE PULSED LIGHT SYSTEM
K021304 · GEX
Big Sky Laser Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jul 23, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
K021516 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 74d
Cleared Jul 23, 2002
MICROPAQ, MODELS 402, 404
K021681 · DRT
Welch Allyn Protocol, Inc.
Cardiovascular · 62d
Cleared Jul 23, 2002
VENTURE HOMEFILL II WITH OXYGEN CONSERVER
K021685 · CAW
Invacare Corp.
Anesthesiology · 62d
Cleared Jul 23, 2002
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
K021764 · BTO
Rusch Intl.
Anesthesiology · 55d
Cleared Jul 23, 2002
R120 MODULAR TOTAL HIP SYSTEM
K021822 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 49d
Cleared Jul 23, 2002
VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG...
K022046 · GGN
Vital Scientific N.V.
Hematology · 29d