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
86425–86448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1999
`THE INSEMINATOR' (PROPOSED)
K984306 · MFD
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 89d
Cleared Mar 01, 1999
HYPERGEL 20% HYPERTONIC SALINE GEL
K984370 · MGQ
Molnlycke Health Care, Inc.
General & Plastic Surgery · 84d
Cleared Mar 01, 1999
SUTURELESS ANCHOR
K984490 · MAI
Innovasive Devices, Inc.
Orthopedic · 74d
Cleared Mar 01, 1999
FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
K984539 · KMF
Ferris Mfg. Corp.
General & Plastic Surgery · 70d
Cleared Mar 01, 1999
SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM,...
K984543 · HSB
Syntec Scientific Corp.
Orthopedic · 70d
Cleared Mar 01, 1999
PRE-THREADED ENDOBUTTON
K984550 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 69d
Cleared Mar 01, 1999
MODIFICATION OF CUTINOVA THIN DRESSING
K984593 · FRO
Beiersdorf-Jobt, Inc.
General & Plastic Surgery · 63d
Cleared Mar 01, 1999
MODIFICATION OF CUTINOVA HYDRO DRESSING
K984595 · FRO
Beiersdorf-Jobt, Inc.
General & Plastic Surgery · 63d
Cleared Mar 01, 1999
MODIFICATION OF CUTINOVA CAVITY DRESSING
K984597 · FRO
Beiersdorf-Jobt, Inc.
General & Plastic Surgery · 63d
Cleared Mar 01, 1999
MODIFICATION OF CUTINOVA FOAM DRESSING
K984599 · FRO
Beiersdorf-Jobt, Inc.
General & Plastic Surgery · 63d
Cleared Mar 01, 1999
ANATOMICA GLENOID COMPONENT
K990136 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 46d
Cleared Mar 01, 1999
D-SIGN V (R&D PROJECT DW267#17)
K990182 · EJH
Ivoclar North America, Inc.
Dental · 40d
Cleared Mar 01, 1999
D-SIGN VI (R&D PROJECT DW266#9)
K990235 · EJH
Ivoclar North America, Inc.
Dental · 35d
Cleared Feb 26, 1999
BIRTCHER UV LAMP
K973865 · MXG
Medfaxx, Inc.
General & Plastic Surgery · 508d
Cleared Feb 26, 1999
MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6
K981125 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 336d
Cleared Feb 26, 1999
MTM BIOSCANNER K TEST STRIPS
K981865 · JMK
Polymer Technology Systems, Inc.
Chemistry · 274d
Cleared Feb 26, 1999
SURE
K982380 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 233d
Cleared Feb 26, 1999
STIMULAN- CALCIUM SULFATE BONE VOID FILLER
K982663 · MQV
Encore Orthopedics, Inc.
Orthopedic · 211d
Cleared Feb 26, 1999
HARWILL MEDICAL U-KLIP UMBILICAL CLAMP
K983204 · HFW
Harwill Medical (Pty) , Ltd.
Obstetrics & Gynecology · 165d
Cleared Feb 26, 1999
7F HYDROLYSER THROMBECTOMY CATHETER
K983534 · QEZ
Cordis Corp.
Cardiovascular · 140d
Cleared Feb 26, 1999
HSV 1+2 IGG ELISA TEST
K983541 · LGC
Gull Laboratories, Inc.
Microbiology · 140d
Cleared Feb 26, 1999
XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER...
K984363 · BTA
Xomed, Inc.
General & Plastic Surgery · 81d
Cleared Feb 26, 1999
ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000
K984503 · KLE
Wallace A. Erickson & Co.
Dental · 70d
Cleared Feb 26, 1999
RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST
K984525 · DKZ
American Bio Medica Corp.
Toxicology · 67d