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
122233–122256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I
K911169 · JJY
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II
K911170 · JIY
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III
K911171 · JJY
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I
K911176 · JJX
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II
K911177 · JJX
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III
K911178 · JJX
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared May 01, 1991
SCHNEIDER WALLSTENT(R)
K911292 · FGE
Pfizer Hospital Products Group, Inc.
Gastroenterology & Urology · 37d
Cleared Apr 30, 1991
BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
K903345 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 279d
Cleared Apr 30, 1991
DR. DEDO'S FAMILY EAR EXAMINATION KIT
K904659 · ERA
Panex Corp.
Ear, Nose, Throat · 197d
Cleared Apr 30, 1991
HT4-SERIES HYSTEROSCOPES AND ACCESSORIES
K905392 · HIH
Frigitronics, Inc.
Obstetrics & Gynecology · 151d
Cleared Apr 30, 1991
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
K905704 · ETY
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 130d
Cleared Apr 30, 1991
AMYLASE
K910158 · JFJ
Pointe Scientific, Inc.,
Chemistry · 105d
Cleared Apr 30, 1991
ARGIPLUS
K910467 · EJS
Argen Precious Metals, Inc.
Dental · 85d
Cleared Apr 30, 1991
CIBA CORNING ACS TSH IMMUNOASSAY
K910981 · JLW
Ciba Corning Diagnostics Corp.
Chemistry · 54d
Cleared Apr 29, 1991
AMS 3000 PORTABLE JET VENTILATOR
K900744 · CBK
Acutronic Medical Systems AG
Anesthesiology · 437d
Cleared Apr 29, 1991
VS-200S JET VENTILATOR
K900745 · CBK
Acutronic Medical Systems AG
Anesthesiology · 437d
Cleared Apr 29, 1991
OLYMPUS JF-UM3-7.5/-12 AND CF-UM3-7.5/-12
K900880 · ITX
Olympus Corp.
Radiology · 427d
Cleared Apr 29, 1991
NORLAND XR26 WHOLE BODY OPTION
K901804 · KGI
Norland Corp.
Radiology · 374d
Cleared Apr 29, 1991
ORTHODONTIC BONDING ADHESIVE CONTROL
K904090 · DYH
Lancer Orthodontics, Inc.
Dental · 235d
Cleared Apr 29, 1991
MULTILAB 2000
K904392 · JAF
Unetixs, Inc.
Radiology · 217d
Cleared Apr 29, 1991
BC 1208 IMPLANT, THREADED EXTERNAL HEX
K904707 · DZE
Minimatic Implant Technology
Dental · 195d
Cleared Apr 29, 1991
S5192R TRANSDUCER
K904951 · MAA
Acuson Corp.
Radiology · 178d
Cleared Apr 29, 1991
IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER
K905039 · DZE
Minimatic Implant Technology
Dental · 174d
Cleared Apr 29, 1991
HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR
K905495 · HIG
Frigitronics, Inc.
Obstetrics & Gynecology · 143d