FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
74473–74496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 23, 2002
INJEX 30 NEEDLE FREE INJECTION SYSTEM
K022148 · KZE
Equidyne Systems, Inc.
General Hospital · 21d
Cleared Jul 23, 2002
ACCU-CHEK COMPACT SYSTEM
K022171 · NBW
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Jul 22, 2002
VECTORSONIC, MODEL VU-200
K020119 · IMG
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 189d
Cleared Jul 22, 2002
OPUS MAGNUM ANCHOR & INSTRUMENT SET
K020172 · MBI
Opus Medical, Inc.
Orthopedic · 186d
Cleared Jul 22, 2002
COLORADO 2 SPINAL SYSTEM
K020247 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 179d
Cleared Jul 22, 2002
MASTERGRAFT RESORBABLE CERAMIC
K020986 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 117d
Cleared Jul 22, 2002
SEARCH EVOLUTION TOTAL KNEE SYSTEM
K021313 · JWH
Aesculap, Inc.
Orthopedic · 88d
Cleared Jul 22, 2002
ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM
K021461 · KWQ
Medtronic Sofamor Danek
Orthopedic · 76d
Cleared Jul 22, 2002
CALIBRATING MATERIAL, BUFFERS, STANDARD
K022027 · JIT
Mission Diagnostics
Chemistry · 31d