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
90505–90528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 28, 1998
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
K974119 · GXZ
Jack'S Electrodes
Neurology · 89d
Cleared Jan 28, 1998
LQUET CANNULA/TROCAR SYSTEM
K974139 · GCJ
Lifequest Endoscopic Technologies, Inc.
General & Plastic Surgery · 86d
Cleared Jan 28, 1998
HM-RUBY
K974142 · GEX
American Lasers, Inc.
General & Plastic Surgery · 86d
Cleared Jan 28, 1998
PARACENTESIS CATHETER DEVICE
K974146 · GCB
Allegiance Healthcare Corp.
General & Plastic Surgery · 86d
Cleared Jan 28, 1998
NARKOMED ULTRASONIC FLOW SENSOR
K974193 · BSZ
Draeger Medical, Inc.
Anesthesiology · 82d
Cleared Jan 28, 1998
DIAMEDIX IS-MEASLES IGG TEST SYSTEM
K974552 · LJB
Diamedix Corp.
Microbiology · 55d
Cleared Jan 28, 1998
STAT TRACKS
K974762 · JJQ
Awareness Technology, Inc.
Chemistry · 40d
Cleared Jan 28, 1998
CARESIDE GLOBULIN
K980055 · JGE
Exigent Diagnostics, Inc.
Chemistry · 22d
Cleared Jan 28, 1998
QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
K980135 · JJS
Radiometer America, Inc.
Chemistry · 13d