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
80809–80832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2000
BROOKER TIBIA NAILS
K002057 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 90d
Cleared Oct 04, 2000
AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES
K002074 · DPS
H&C Medical Devices Spa
Cardiovascular · 86d
Cleared Oct 04, 2000
INQWIRE DIAGNOSTIC GUIDE WIRE
K002289 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 69d
Cleared Oct 04, 2000
EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
K002484 · JDX
Electro Medical Systems SA
Orthopedic · 51d
Cleared Oct 04, 2000
ASCENT XXL CLOSED BOX FEMORAL COMPONENT
K002772 · JWH
Biomet, Inc.
Orthopedic · 28d
Cleared Oct 04, 2000
PRESSURE WIRE SENSOR, MODEL 12003/12303
K002962 · DQX
Radi Medical Systems AB
Cardiovascular · 12d
Cleared Oct 03, 2000
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
K001703 · GAW
Abbott Vascular, Inc.
General & Plastic Surgery · 120d
Cleared Oct 03, 2000
BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID
K002213 · FMI
Hunter Research Laboratories, Inc.
General Hospital · 74d
Cleared Oct 03, 2000
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER
K002490 · LNH
Fonar Corp.
Radiology · 50d
Cleared Oct 03, 2000
POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K002568 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 46d
Cleared Oct 03, 2000
MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE
K002836 · MQL
Sage Biopharma
Obstetrics & Gynecology · 21d
Cleared Oct 02, 2000
TORNIER TOTAL ELBOW PROSTHESIS
K000003 · JDC
Tornier
Orthopedic · 273d
Cleared Oct 02, 2000
DISPOSABLE H-PE MICROKERATOME BLADES
K001464 · HNO
Oasis
Ophthalmic · 145d
Cleared Oct 02, 2000
GLUCANPRO CREAM
K002077 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 84d
Cleared Oct 02, 2000
BETA GLUCAN GEL (MACROPRO GEL)
K002078 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 84d
Cleared Oct 02, 2000
BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
K002294 · CDZ
Biocheck, Inc.
Chemistry · 67d
Cleared Oct 02, 2000
CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15
K002296 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 66d
Cleared Oct 02, 2000
ENDIUS ENDOSCOPIC ACCESS SYSTEM
K002437 · HRX
Endius, Inc.
Orthopedic · 54d
Cleared Oct 02, 2000
STRYKER NAVIGATION SYSTEM - ENT MODULE
K002732 · HAW
Stryker Corp.
Neurology · 31d
Cleared Sep 29, 2000
OLYMPIC WARM-UP
K001056 · ILY
Olympic Medical Corp.
Physical Medicine · 179d
Cleared Sep 29, 2000
OMNIPORT
K002013 · GCJ
Advanced Surgical Concepts (Asc)
General & Plastic Surgery · 88d
Cleared Sep 29, 2000
BRAVO PH MONITORING SYSTEM
K002028 · FFT
Endonetics, Inc.
Gastroenterology & Urology · 88d
Cleared Sep 29, 2000
MODIFICATION TO: PRONTO DRY
K002451 · LYR
Medical Instruments Corporation, AG
Microbiology · 51d
Cleared Sep 29, 2000
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS...
K002710 · HRS
Synthes (Usa)
Orthopedic · 29d