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
75001–75024 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 22, 2002
XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
K022070 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 26d
Cleared Jul 22, 2002
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
K022118 · JHX
Diagnostic Products Corp.
Chemistry · 21d
Cleared Jul 19, 2002
ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
K011591 · ESW
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 421d
Cleared Jul 19, 2002
CHEMWELL, ALSO KNOWN AS PROJECT 2900
K013420 · JLW
Awareness Technology, Inc.
Chemistry · 277d
Cleared Jul 19, 2002
KOLIBRI IGS SYSTEMS
K014256 · HAW
Brainlab AG
Neurology · 205d
Cleared Jul 19, 2002
SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND...
K020910 · GXZ
The Electrode Store, Inc.
Neurology · 121d
Cleared Jul 19, 2002
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE
K021279 · MHX
Datex-Ohmeda
Cardiovascular · 88d
Cleared Jul 19, 2002
SECURE SOFT
K021437 · EBI
Imtec Corp.
Dental · 74d
Cleared Jul 19, 2002
BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET
K021475 · FMI
Bd
General Hospital · 72d
Cleared Jul 19, 2002
LIGHT CURE DENTAL DAM
K021524 · EIE
Prime Dental Manufacturing, Inc.
Dental · 70d
Cleared Jul 19, 2002
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572 · DCN
Beckman Coulter, Inc.
Immunology · 66d
Cleared Jul 19, 2002
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
K021671 · LBS
Jas Diagnostics, Inc.
Chemistry · 59d
Cleared Jul 19, 2002
ADMIRA PROTECT
K021844 · EBC
Voco GmbH
Dental · 44d
Cleared Jul 19, 2002
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS...
K022000 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 19, 2002
MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)
K022026 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 28d