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
91513–91536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1997
SOLIDEX
K972292 · EBF
Shofu Dental Corp.
Dental · 132d
Cleared Oct 29, 1997
THE MERETEK UBT BREATH TEST FOR H.PYLORI
K972352 · MSQ
Meretek Diagnostics, Inc.
Microbiology · 127d
Cleared Oct 29, 1997
ARTISAN PULSE LAVAGE SYSTEM
K972551 · FQH
Howmedica Corp.
General Hospital · 113d
Cleared Oct 29, 1997
ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE
K972757 · LZA
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 98d
Cleared Oct 29, 1997
DURATION STABILIZED UHMWPE KNEE COMPONENTS
K972863 · JWH
Howmedica Corp.
Orthopedic · 86d
Cleared Oct 29, 1997
DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS
K972864 · JWH
Howmedica Corp.
Orthopedic · 86d
Cleared Oct 29, 1997
LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE
K972984 · GCJ
Lerner Medical, Inc.
General & Plastic Surgery · 79d
Cleared Oct 29, 1997
POWERSTAR BIPOLAR SCISSORS
K973173 · GEI
Ethicon, Inc.
General & Plastic Surgery · 65d
Cleared Oct 29, 1997
ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
K973196 · MID
Zeus Scientific, Inc.
Immunology · 64d
Cleared Oct 29, 1997
COSMAN COAGULATOR (CC-1) SYSTEM
K973297 · GEI
Radionics, Inc.
General & Plastic Surgery · 57d
Cleared Oct 29, 1997
MATRIX PLUS MULTI-CALIBRATOR KIT
K973345 · JIX
Verichem Laboratories, Inc.
Chemistry · 54d
Cleared Oct 29, 1997
TUTTNAUER TABLE-TOP AUTOCLAVE
K973550 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 41d
Cleared Oct 29, 1997
COULTER AC.T DIFF ANALYZER
K973634 · GKZ
Coulter Corp.
Hematology · 35d
Cleared Oct 29, 1997
MSI PRESSURE INFUSOR
K973843 · KZD
Smith Assoc.
General Hospital · 21d
Cleared Oct 29, 1997
AIR CONDUCTION HEARING AID
K973846 · ESD
Baron Trading, Inc.
Ear, Nose, Throat · 21d
Cleared Oct 29, 1997
IMMUSURE
K973894 · JJY
Quantimetrix Corp.
Chemistry · 15d
Cleared Oct 29, 1997
2 GALLON ALTERNATE CARE SHARPS CONTAINER
K973911 · FMI
Sage Products, Inc.
General Hospital · 15d
Cleared Oct 28, 1997
CSCO FOREHEAD FIXATION SYSTEM
K963502 · MBI
Howmedica Corp.
Orthopedic · 420d
Cleared Oct 28, 1997
CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM
K970264 · DYB
Cordis Webster, Inc.
Cardiovascular · 278d
Cleared Oct 28, 1997
CHASE TEMPERATURE PROBE
K971013 · DTN
Chase Medical, Inc.
Cardiovascular · 222d
Cleared Oct 28, 1997
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE-...
K972271 · KXK
Ml Strategies, Inc.
Radiology · 132d
Cleared Oct 28, 1997
ERCO-RIBBON
K972353 · LKY
Ercons, Inc.
Gastroenterology & Urology · 126d
Cleared Oct 28, 1997
CRICKET 2000 RECORDING PULSE OXIMETER
K972829 · DQA
Respironics, Inc.
Anesthesiology · 90d
Cleared Oct 28, 1997
DERMA K LASER SYSTEM
K972872 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 85d