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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
150385–150408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1984
HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STI
K843637 · GZJ
Therapeutic Equipment Corp.
Neurology · 73d
Cleared Nov 29, 1984
CYBEX TORSO TESTING & REHABILITATION
K843739 · IKK
Cybex
Physical Medicine · 65d
Cleared Nov 29, 1984
BACTERIURIA DETECT DEVICE, MULTI SAMPLER
K843833 · JXA
Applied Polytechnology, Inc.
Microbiology · 59d
Cleared Nov 29, 1984
BACTERIURIA DETECT. DEVICE APTEK II
K843834 · JXA
Applied Polytechnology, Inc.
Microbiology · 59d
Cleared Nov 29, 1984
EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR
K843955 · DTZ
Extracorporeal Medical Specialities,...
Cardiovascular · 51d
Cleared Nov 29, 1984
VISITEC MAGNIFYING SPECTACLES
K844038 · HOI
Visitec Co.
Ophthalmic · 44d
Cleared Nov 29, 1984
UNITED SKIN BARRIERS
K844046 · EXB
Howmedica Corp.
Gastroenterology & Urology · 43d
Cleared Nov 29, 1984
PRUITT IRRIGATION AND OCCLUSION CATHETER
K844094 · GBX
Bionomy, Inc.
General & Plastic Surgery · 42d
Cleared Nov 29, 1984
NUCLEOTOME
K844131 · HSZ
Medical Instrument Development...
Orthopedic · 37d
Cleared Nov 29, 1984
MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE
K844320
Belgium Surgical Co.
General & Plastic Surgery · 23d
Cleared Nov 29, 1984
STONE, INSTRUMENT HONING
K844379
Treace Medical, Inc.
General & Plastic Surgery · 16d
Cleared Nov 29, 1984
JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN
K844406 · EXB
Johnson & Johnson Professionals, Inc.
Gastroenterology & Urology · 16d
Cleared Nov 29, 1984
POWER PACK 160 SIEMENS-ELEMA AB
K844590 · CBK
Siemens Elema AB
Anesthesiology · 3d
Cleared Nov 28, 1984
MODEL 800-A VERI/PPR
K840099 · GZJ
Verite
Neurology · 323d
Cleared Nov 28, 1984
CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2
K842754 · FLG
Custom Ultrasonics
General Hospital · 135d
Cleared Nov 28, 1984
MIXING CONTAINER
K843954 · KPE
American Mcgaw
General Hospital · 50d
Cleared Nov 28, 1984
COLOR OPTIC CORNEAL EYE SHIELD
K843961 · HOY
Colors IN Optics , Ltd.
Ophthalmic · 48d
Cleared Nov 28, 1984
DERATA MEDI-JECTOR III
K844111 · KZE
Derata Corp.
General Hospital · 36d
Cleared Nov 28, 1984
DESERET SUBCLAVIAN JUGULAR CATHETER SET
K844113 · FOZ
Parke-Davis Co.
General Hospital · 36d
Cleared Nov 28, 1984
DESERET DENTRAL LINE CATHETER
K844219 · FOZ
Parke-Davis Co.
General Hospital · 28d
Cleared Nov 28, 1984
NUTRIBAG MIXING CONTAINER -2000 ML
K844410 · KPE
Medical & Pharmaceutical Supplies, Inc.
General Hospital · 14d
Cleared Nov 27, 1984
BIPOLAR ENDOCARDIAL LEAD 406L
K841227 · DTD
Siemens Elema AB
Cardiovascular · 250d
Cleared Nov 27, 1984
ENZYME IMMUNOASSAY FOR DETECTION HORM
K841545 · CEP
Btc Diagnostics, Inc.
Chemistry · 225d
Cleared Nov 27, 1984
SCATAID
K842706 · DXG
Sc Applied Technology, Inc.
Cardiovascular · 138d