FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
125521–125544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 1990
ENTERA-FLO ENTERAL FEEDING PUMP
K894506 · FRN
Delmed, Inc.
General Hospital · 383d
Cleared Aug 06, 1990
LOFRIC(R), LOFRIC(R) CATH-KIT
K896750 · KOD
Astra Meditec AB
Gastroenterology & Urology · 249d
Cleared Aug 06, 1990
L'LL SQUIRT GUM ORAL RINSE DEVICE
K897053 · EFS
James R. Powell
Dental · 231d
Cleared Aug 06, 1990
MEDELA BATTERY OPERATED BREAST PUMP
K901344 · HGX
Medela, Inc.
Obstetrics & Gynecology · 137d
Cleared Aug 06, 1990
DEGUFILL (R) BOND
K901870 · KLE
Degussa AG
Dental · 104d
Cleared Aug 06, 1990
DEGUFILL (R) ADHESIVE
K901871 · KLE
Degussa AG
Dental · 104d
Cleared Aug 06, 1990
BECKMAN ANTITHROMBIN III REAGENT KIT
K901977 · JBQ
Beckman Instruments, Inc.
Hematology · 96d
Cleared Aug 06, 1990
MODIFIED UNI-STICK PLASTIC LIGATURE
K902064 · EJF
American Orthodontics
Dental · 90d
Cleared Aug 06, 1990
HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER
K902068 · EWO
Starkey Laboratories, Inc.
Ear, Nose, Throat · 91d
Cleared Aug 06, 1990
INTRIGUE CERAMIC BRACKET
K902075 · NJM
Lancer Orthodontics, Inc.
Dental · 90d
Cleared Aug 06, 1990
HEM-O-LOK(TM)
K902108 · FZP
Edward Weck, Inc.
General & Plastic Surgery · 90d
Cleared Aug 06, 1990
MERCURY RHINOMANOMETER
K902120 · BXQ
Life-Tech Intl., Inc.
Anesthesiology · 87d
Cleared Aug 06, 1990
ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.
K902213 · MCS
Gen-Probe, Inc.
Microbiology · 82d
Cleared Aug 06, 1990
ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K902556 · GFO
Analytical Control Systems, Inc.
Hematology · 59d
Cleared Aug 06, 1990
PERI-BOTTLE
K902830 · HED
Orion Life Systems, Inc.
Obstetrics & Gynecology · 39d
Cleared Aug 06, 1990
ARGENCO 6 TYPE II DENTAL GOLD ALLOY
K902902 · EJT
Argen Precious Metals, Inc.
Dental · 34d
Cleared Aug 06, 1990
ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR.
K902908 · MCT
Gen-Probe, Inc.
Microbiology · 35d
Cleared Aug 06, 1990
ARGENCO 2 TYPE III DENTAL GOLD ALLOY
K902966 · EJT
Argen Precious Metals, Inc.
Dental · 31d
Cleared Aug 06, 1990
ARGENCO NORDIC
K903274 · EJT
Argen Precious Metals, Inc.
Dental · 13d
Cleared Aug 06, 1990
ARGENCO 28
K903278 · EJT
Argen Precious Metals, Inc.
Dental · 13d
Cleared Aug 06, 1990
ARGENCO 27
K903280 · EJT
Argen Precious Metals, Inc.
Dental · 13d
Cleared Aug 03, 1990
DEN-MAT CERINATE PORCELAIN
K895731 · EIH
Den-Mat Corp.
Dental · 311d
Cleared Aug 03, 1990
BEAR CEM CONTROLLER
K900637 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 175d
Cleared Aug 03, 1990
BABY E.T. TAPE II
K900912 · CBH
B&B Medical Technologies, Inc.
Anesthesiology · 157d