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
120145–120168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1991
DEGUBOND LITE
K912493 · EJS
Degussa AG
Dental · 77d
Cleared Aug 20, 1991
MINITROP AEROSOL UNIT
K912566 · CAF
Heyer America, Inc.
Anesthesiology · 70d
Cleared Aug 20, 1991
CLEARFIL LINER BOND SYSTEM
K912707 · KLE
Kuraray Co.
Dental · 62d
Cleared Aug 20, 1991
CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM
K912708 · EBF
Kuraray Co.
Dental · 62d
Cleared Aug 20, 1991
ENDO-CORE
K912720 · ELR
Metalor Dental USA Corp.
Dental · 63d
Cleared Aug 20, 1991
AUROFILM MP
K912721 · EJT
Metalor Dental USA Corp.
Dental · 63d
Cleared Aug 20, 1991
PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM)
K912853 · FYD
Precision Laser Products, Inc.
General Hospital · 53d
Cleared Aug 20, 1991
AVI MODEL 270CI INFUSION PUMP
K912875 · FRN
3M Avi, Inc.
General Hospital · 50d
Cleared Aug 20, 1991
SPECTRAL EEG MONITOR MODEL B500
K913051 · OLT
Biometrak Corp.
Neurology · 42d
Cleared Aug 19, 1991
UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500
K905107 · IPF
Universal Technology Systems, Inc.
Physical Medicine · 279d
Cleared Aug 19, 1991
SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K910342 · IYO
Medison Co., Ltd.
Radiology · 203d
Cleared Aug 19, 1991
MR-5200 FULL DISCLOSURE SYSTEM
K911257 · DSH
Mennen Medical, Inc.
Cardiovascular · 151d
Cleared Aug 19, 1991
22MM ID/OD ADAPTER
K911263 · CAI
Monaghan Medical Corp.
Anesthesiology · 150d
Cleared Aug 19, 1991
EAGLE NUCLEAR IMAGING SYSTEM
K911290 · KPS
Trionix Research Laboratory, Inc.
Radiology · 147d
Cleared Aug 19, 1991
I.V. SKY-HOOK
K912010 · FOX
Dina - Industria, Comercio E...
General Hospital · 105d
Cleared Aug 19, 1991
AGC REVISION KNEE PROTHESIS
K912245 · JWH
Biomet, Inc.
Orthopedic · 90d
Cleared Aug 19, 1991
BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF
K912284 · GEX
Douglas James Donaldson Compliance...
General & Plastic Surgery · 104d
Cleared Aug 16, 1991
OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS
K905223 · DZE
Universal Implant Systems, Inc.
Dental · 269d
Cleared Aug 16, 1991
02-10,001
K910062 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 219d
Cleared Aug 16, 1991
BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
K910190 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 212d
Cleared Aug 16, 1991
NOBELPHARMA CERAONE ABUTMENT SYSTEM
K910611 · DZE
Nobelpharma USA, Inc.
Dental · 185d
Cleared Aug 16, 1991
BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF
K910846 · EZC
C.R. Bard, Inc.
Gastroenterology & Urology · 170d
Cleared Aug 16, 1991
CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)
K910938 · JXG
Codman & Shurtleff, Inc.
Neurology · 163d
Cleared Aug 16, 1991
SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)
K911217 · KLI
Serono-Baker Diagnostics, Inc.
Chemistry · 150d