FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73681–73704 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 2002
MIRAGE FULL FACE MASK SERIES 2
K023306 · BZD
Resmed, Ltd.
Anesthesiology · 55d
Cleared Nov 27, 2002
MODIFICATION TO RADIAL HEAD IMPLANT
K023604 · KWI
Avanta Orthopaedics, Inc.
Orthopedic · 30d
Cleared Nov 27, 2002
DATEX-OHMEDA HMEF MINI
K023641 · CAH
Datex-Ohmeda
General Hospital · 28d
Cleared Nov 27, 2002
CADENCE PEEK CEMEENT RESTRICTOR
K023647 · JDK
Spinal Concepts, Inc.
Orthopedic · 28d
Cleared Nov 27, 2002
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K023699 · LCX
Unipath , Ltd.
Chemistry · 23d
Cleared Nov 26, 2002
CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
K013072 · MQV
Synthes
Orthopedic · 439d
Cleared Nov 26, 2002
RANDOX HAEMOGLOBIN A1C
K021897 · LCP
Randox Laboratories, Ltd.
Chemistry · 169d
Cleared Nov 26, 2002
SAFETOUCH
K022861 · NHM
Rusin Medical Devices
Obstetrics & Gynecology · 90d
Cleared Nov 26, 2002
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022887 · KWH
Osteomed Corp.
Orthopedic · 88d
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