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
73177–73200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 2002
ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)
K023033 · MQL
Intl., Inc.
Obstetrics & Gynecology · 75d
Cleared Nov 26, 2002
CIRCUIT TUBINGS WITH X-COATING
K023056 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 74d
Cleared Nov 26, 2002
INNOVA 4100
K023178 · OWB
Ge Medical Systems, Inc.
Radiology · 64d
Cleared Nov 26, 2002
MY BREAST FRIEND, BREAST SELF-EXAM PAD
K023390 · IXH
Mbf Sales, LLC
Radiology · 48d
Cleared Nov 26, 2002
FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
K023479 · HEB
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 40d
Cleared Nov 26, 2002
HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)
K023530 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 36d
Cleared Nov 26, 2002
SYNTHES CERVIFIX/ AXON
K023675 · KWP
Synthes (Usa)
Orthopedic · 25d
Cleared Nov 26, 2002
RENEGADE STC 18 MICROCATHETER
K023681 · DQO
Boston Scientific Corp
Cardiovascular · 25d
Cleared Nov 26, 2002
CANON FULL AUTO TONOMETER TX-F
K023816 · HKX
Canon, Inc.-Utsunomiya Optical...
Ophthalmic · 11d
Cleared Nov 25, 2002
LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE
K022686 · FED
Lap Surgical Systems, LLC
Gastroenterology & Urology · 104d
Cleared Nov 25, 2002
VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM
K022800 · DHN
Hyperion, Inc.
Immunology · 94d
Cleared Nov 25, 2002
FOTONA TANDEM LASER SYSTEM
K022837 · GEX
Fotona D.D.
General & Plastic Surgery · 90d
Cleared Nov 25, 2002
FOTONA DUALIS ER:YAG/KTP LASER SYSTEM
K022838 · GEX
Fotona D.D.
General & Plastic Surgery · 90d
Cleared Nov 25, 2002
FOTONA DUALIS PLUS ND:YAG LASER SYSTEM
K022839 · GEX
Fotona D.D.
General & Plastic Surgery · 90d
Cleared Nov 25, 2002
ENDOTACK
K022853 · MBI
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 90d
Cleared Nov 25, 2002
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022886 · KWH
Osteomed Corp.
Orthopedic · 87d
Cleared Nov 25, 2002
ASCENSION SILLICONE MCP
K022892 · KYJ
Ascension Orthopedics, Inc.
Orthopedic · 87d
Cleared Nov 25, 2002
MICROHYBRID 11
K022971 · EBF
Ab Ardent
Dental · 80d
Cleared Nov 25, 2002
RADLITE TISSUE RETRACTOR SYSTEM
K022989 · FSW
Genzyme Biosurgery
General & Plastic Surgery · 77d
Cleared Nov 25, 2002
DEMETECH SILK NONABSORBABLE SUTURE
K023029 · GAP
Demetech Corp.
General & Plastic Surgery · 75d
Cleared Nov 25, 2002
DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
K023066 · HBB
Sodemsystems
Neurology · 70d
Cleared Nov 25, 2002
BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE
K023075 · JKA
Bd Vacutainer Systems Preanalyical...
Chemistry · 70d
Cleared Nov 25, 2002
ACCESS HYPERSENSITIVE HTSH ASSAY
K023093 · JLW
Beckman Coulter, Inc.
Chemistry · 68d
Cleared Nov 25, 2002
ALOCLAIR ORAL RINSE
K023155 · OLR
Sinclair Pharmaceuticals, Ltd.
General & Plastic Surgery · 63d