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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68809–68832 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2004
INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)
K032631 · FYA
Lac Mac, Ltd.
General Hospital · 163d
Cleared Feb 05, 2004
HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM
K033089 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 129d
Cleared Feb 05, 2004
DEPUY SIGMA TIBIAL INSERTS
K033272 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 118d
Cleared Feb 05, 2004
SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K033382 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 105d
Cleared Feb 05, 2004
HEARTRAK SMART AT/HEARTRAK SMART2
K033451 · DXH
Universal Medical, Inc.
Cardiovascular · 98d
Cleared Feb 05, 2004
INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER
K033527 · DYB
B.Braun Medical, Inc.
Cardiovascular · 90d
Cleared Feb 05, 2004
SMARTSET GHV GENTAMICIN BONE CEMENT
K033563 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Feb 05, 2004
SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
K033618 · HSB
Synthes (Usa)
Orthopedic · 79d
Cleared Feb 05, 2004
AEGIS PIT & FISSURE SEALANT WITH ACP
K033751 · EBC
Harry J. Bosworth Co.
Dental · 66d
Cleared Feb 05, 2004
ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K033777 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 63d
Cleared Feb 05, 2004
SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
K033844 · KWQ
Synthes (Usa)
Orthopedic · 56d
Cleared Feb 05, 2004
MODIFICATION TO DIADEXUS PLAC TEST
K040101 · NOE
Diadexus, Inc.
Chemistry · 16d
Cleared Feb 04, 2004
APEX MEDICAL CPAP RT 21XX
K022650 · BZD
Apex Medical Corp.
Anesthesiology · 544d
Cleared Feb 04, 2004
AMSURE RED RUBBER URETHRAL CATHETER
K030293 · EYB
Amsino International, Inc.
Gastroenterology & Urology · 372d
Cleared Feb 04, 2004
BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM
K032216 · NHN
Bioptron AG
Physical Medicine · 198d
Cleared Feb 04, 2004
DURAMAX .018 BILIARY STENT SYSTEM
K032436 · FGE
Avantec Vascular Corp.
Gastroenterology & Urology · 181d
Cleared Feb 04, 2004
PRESS-MATE BX-10 VITAL SIGN MONITOR
K032857 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 145d
Cleared Feb 04, 2004
HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE
K032969 · GEI
Helica Instruments, Ltd.
General & Plastic Surgery · 134d
Cleared Feb 04, 2004
SIMULIX EVOLUTION
K033470 · KPQ
Nucletron Corporation
Radiology · 93d
Cleared Feb 04, 2004
PHOSPHOLIN ES AND CALCIUM CHLORIDE
K033471 · GGW
R2 Diagnostics, Inc.
Hematology · 93d
Cleared Feb 04, 2004
BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
K033497 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 91d
Cleared Feb 04, 2004
MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT
K033652 · GEI
Zimmer, Inc.
General & Plastic Surgery · 76d
Cleared Feb 04, 2004
POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
K033706 · LPS
Polymedco, Inc.
Chemistry · 70d
Cleared Feb 04, 2004
BARD TIGERTAIL URETERAL CATHETER
K033719 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 70d