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
99625–99648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1995
AUTO SUTURE SUTURE CLOSURE
K954853 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 58d
Cleared Dec 20, 1995
TEST, RHEUMATOID FACTOR
K955086 · DHR
Polymedco, Inc.
Immunology · 43d
Cleared Dec 20, 1995
AMERLITE MAB FT4 ASSAY
K955097 · CEC
Kodak Clinical Diagnostics, Ltd.
Chemistry · 43d
Cleared Dec 20, 1995
DOCUMENT TDM ULTRA UNASSAYED CONTROL
K955155 · DIF
Casco Standards
Chemistry · 37d
Cleared Dec 20, 1995
TOTAL BILIRUBIN PROCEDURE
K955300 · CIG
Data Medical Associates, Inc.
Chemistry · 30d
Cleared Dec 19, 1995
SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
K936294 · KWP
Sofamor Danek Mfg., Inc.
Orthopedic · 739d
Cleared Dec 19, 1995
SPERMICIDALLY LUBRICATED CONDOM
K940047 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 713d
Cleared Dec 19, 1995
IMAGN(TM) 2000 SYSTEM
K945756 · GKZ
Buckman Co., Inc.
Hematology · 391d
Cleared Dec 19, 1995
RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE
K945930 · HIS
Line One Laboratories & Trading Co.
Obstetrics & Gynecology · 379d
Cleared Dec 19, 1995
VASCUTEK GELWEAVE VASCULAR GRAFT
K952293 · DSY
Vascutek, Ltd.
Cardiovascular · 217d
Cleared Dec 19, 1995
BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL
K952922 · LYC
Orthovita Co.
Dental · 176d
Cleared Dec 19, 1995
OLYMPUS HIGH FLOW INSUFFLATION UNIT
K953162 · HIF
Olympus America, Inc.
Obstetrics & Gynecology · 165d
Cleared Dec 19, 1995
CARDIOVIT AT-1C, AT-2C
K953396 · LOS
Schiller America, Inc.
Cardiovascular · 152d
Cleared Dec 19, 1995
KIS II LG HEX SCREW & CYLINDER IMPLANTS
K953558 · DZE
The Implant Center of the Palm Beaches
Dental · 154d
Cleared Dec 19, 1995
CLAMP ASSEMBLY
K953599 · KWP
J.B.S., S.A.
Orthopedic · 139d
Cleared Dec 19, 1995
MEPORE (6X7)
K954274 · KMF
Scott Health Care
General & Plastic Surgery · 97d
Cleared Dec 19, 1995
MEDOX CHAMPION COMPACT NEBULIZER
K954327 · CAF
Medox Corp.
Anesthesiology · 95d
Cleared Dec 19, 1995
INSEMI-CATH II
K954398 · MFD
Cook Urological, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 19, 1995
GO INTRAMEDULLARY NAIL LOCKING SCREW
K954511 · HWC
Genesis Orthopedics, Inc.
Orthopedic · 82d
Cleared Dec 19, 1995
RIGID NEUROVIEW ENDOSCOPE
K954899 · GWG
Neuro Navigational Corp.
Neurology · 55d
Cleared Dec 19, 1995
PROTEC GAUZE SPONGE
K955321 · EFQ
Derivados DE Gasa, S.A. DE C.V.
General & Plastic Surgery · 29d
Cleared Dec 19, 1995
PROTEC X-RAY DETECTABLE GAUZE SPONGE
K955322 · GDY
Derivados DE Gasa, S.A. DE C.V.
General & Plastic Surgery · 29d
Cleared Dec 19, 1995
CYBER III OPTION UM, UC312, UC10, UCIC
K955359 · ESD
Qualitone
Ear, Nose, Throat · 27d
Cleared Dec 18, 1995
INFUSION SET
K950970 · FPA
Surgiplast , Ltd.
General Hospital · 291d