FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91009–91032 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 1998
TTM5000 TELEPHONIC EKG MONITOR
K973267 · DXH
Hds Medical, Inc.
Cardiovascular · 153d
Cleared Jan 29, 1998
EASYSAFE RETRACTING NEEDLE SYRINGE
K973792 · MEG
Saf-T-Med, Inc.
General Hospital · 115d
Cleared Jan 29, 1998
SAFEPASS STERILIZATION POUCH
K973981 · KCT
Adroit Medical Systems, Inc.
General Hospital · 101d
Cleared Jan 29, 1998
VACUDAP, MODEL 2000, 2001
K974112 · KPR
Victoreen, Inc.
Radiology · 90d
Cleared Jan 29, 1998
LUBRICATED BAGGY TACTYLON CONDOM
K974121 · MOL
Sensicon Corp.
Obstetrics & Gynecology · 90d
Cleared Jan 29, 1998
VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE
K974130 · LMD
Dejarnette Research Systems
Radiology · 87d
Cleared Jan 29, 1998
POSITION PENTA, POSITION PENTA QUICK
K974231 · ELW
Espe GmbH & Co. Kg.
Dental · 78d
Cleared Jan 29, 1998
VITALESCENCE
K974282 · EBF
Ultradent Products, Inc.
Dental · 76d
Cleared Jan 29, 1998
PQ 1
K974283 · KLE
Ultradent Products, Inc.
Dental · 76d
Cleared Jan 29, 1998
ZEROWET SPLASHIELD
K974288 · KYZ
Zerowet, Inc.
General Hospital · 76d
Cleared Jan 29, 1998
SURGEON'S GLOVES
K974356 · KGO
American Health Products, Inc.
General Hospital · 71d
Cleared Jan 29, 1998
CLEARFIL LINER BOND 2V
K974486 · KLE
Kuraray America, Inc.
Dental · 64d
Cleared Jan 29, 1998
HYDROGUM
K974704 · ELW
Zhermack S.P.A.
Dental · 44d
Cleared Jan 29, 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES
K974887 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 30d
Cleared Jan 29, 1998
POWDERED NITRILE EXAMINATION GLOVES
K980149 · LZA
Masju Sdn. Bhd.
General Hospital · 13d
Cleared Jan 28, 1998
BACTEC MYCO/F LYTIC CULTURE VIALS
K970333 · MDB
Becton Dickinson Microbiology Systems
Microbiology · 365d
Cleared Jan 28, 1998
RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971636 · JTN
Oxoid , Ltd.
Microbiology · 271d
Cleared Jan 28, 1998
MIS ELECTROSURGICAL ELECTRODE
K971829 · GEI
E-Tek, Inc.
General & Plastic Surgery · 257d
Cleared Jan 28, 1998
EMS NASAL CPAP MASK
K972605 · BZD
Engineered Medical Systems
Anesthesiology · 201d
Cleared Jan 28, 1998
STC METHAMPHETAMINE MICRO-PLATE EIA
K972989 · DKZ
OraSure Technologies, Inc.
Toxicology · 169d
Cleared Jan 28, 1998
FOUNDATION POROUS ACETABULAR SYSTEM
K973119 · LPH
Encore Orthopedics, Inc.
Orthopedic · 161d
Cleared Jan 28, 1998
FOUNDATION POROUS COATED HEMISPHERICAL SHELL
K974093 · LPH
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Jan 28, 1998
FOUNDATION POROUS COATED FLARED RIM SHELL
K974095 · LPH
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Jan 28, 1998
PUBOUURETHRAL SLING
K974098 · OTN
Ethicon, Inc.
Gastroenterology & Urology · 90d