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
79273–79296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2001
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)
K010088 · GWQ
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 26, 2001
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
K010089 · GWQ
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 26, 2001
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
K010090 · GWF
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 26, 2001
ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC)...
K010256 · LPL
Opti-Centre Laboratories
Ophthalmic · 56d
Cleared Mar 26, 2001
AMS FASCIAL-ANCHORING SYSTEM
K010277 · NEH
American Medical Systems, Inc.
General & Plastic Surgery · 55d
Cleared Mar 26, 2001
PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700,...
K010403 · NBW
Home Diagnostics, Inc.
Chemistry · 42d
Cleared Mar 23, 2001
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
K000977 · DTR
Olson Medical Sales, Inc.
Cardiovascular · 361d
Cleared Mar 23, 2001
BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING...
K003752 · JLW
Biosafe Laboratories, Inc.
Chemistry · 108d
Cleared Mar 23, 2001
JAS MAGNESIUM REAGENT
K003835 · JGJ
Jas Diagnostics, Inc.
Chemistry · 101d
Cleared Mar 23, 2001
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
K010389 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 42d
Cleared Mar 23, 2001
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
K010598 · JPK
Quantimetrix Corp.
Hematology · 23d
Cleared Mar 23, 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES...
K010636 · MVN
Ciba Vision Corporation
Ophthalmic · 18d
Cleared Mar 23, 2001
FLEXI-SITE SP02 EAR SENSOR
K010718 · DPZ
Epic Medical Equipment Services, Inc.
Anesthesiology · 11d
Cleared Mar 22, 2001
MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300
K000724 · KDI
Medica S.R.L.
Gastroenterology & Urology · 381d
Cleared Mar 22, 2001
K.E.A.T.
K002154 · KPI
Emd Electronic Medical Devices, Corp.
Gastroenterology & Urology · 248d
Cleared Mar 22, 2001
LDOB OCCLUSION BALLOON CATHETER
K002286 · MJN
Cook, Inc.
Cardiovascular · 238d
Cleared Mar 22, 2001
BLASTASSIST SYSTEM
K003156 · MQL
Medicult A/S
Obstetrics & Gynecology · 163d
Cleared Mar 22, 2001
SYNVITRO FLUSH
K003163 · MQL
Medicult A/S
Obstetrics & Gynecology · 163d
Cleared Mar 22, 2001
SUPRASPERM SYSTEM
K003404 · MQL
Medicult A/S
Obstetrics & Gynecology · 141d
Cleared Mar 22, 2001
ENDIUS BIPOLAR SHEATH
K003897 · GEI
Endius, Inc.
General & Plastic Surgery · 94d
Cleared Mar 22, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K003929 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 92d
Cleared Mar 22, 2001
DAUM DOUBLE-SHOOT BISOPSY GUN
K010037 · KNW
Daum GmbH
Gastroenterology & Urology · 77d
Cleared Mar 22, 2001
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
K010158 · GGO
Sigma Diagnostics, Inc.
Hematology · 64d
Cleared Mar 22, 2001
MCC-MIV ONE 2 ONE SOFTWARE
K010364 · ITI
Invacare Corp.
Physical Medicine · 43d