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
73153–73176 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2003
MOSS MIAMI SPINAL SYSTEM PIN NUT
K023804 · KWP
Depuyacromed
Orthopedic · 70d
Cleared Jan 23, 2003
RAPID THERMAL EXCHANGE SYSTEM
K023934 · DWJ
Avacore Technologies, Inc.
Cardiovascular · 58d
Cleared Jan 23, 2003
SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K023941 · KTT
Synthes (Usa)
Orthopedic · 58d
Cleared Jan 23, 2003
OSTEO-CABLE SLEEVE
K024022 · HXN
Biomet, Inc.
Orthopedic · 49d
Cleared Jan 23, 2003
ASCENSIA GLUCOFACTS
K024234 · NBW
Bayer Corp.
Chemistry · 31d
Cleared Jan 23, 2003
SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K024326 · KWQ
Spinal Concepts, Inc.
Orthopedic · 28d
Cleared Jan 23, 2003
FREEDOM CONSTRAINED LINERS
K030047 · KWZ
Biomet, Inc.
Orthopedic · 17d
Cleared Jan 23, 2003
TRIAGE CARDIAC CONTROLS
K030089 · JJY
Biosite Incorporated
Chemistry · 13d
Cleared Jan 22, 2003
EXEL SECURETOUCH PTP SYRINGE
K011754 · MEG
Exelint Intl. Co.
General Hospital · 595d
Cleared Jan 22, 2003
STRYKER NAVIGATION SYSTEM - HIP MODULE
K022365 · HAW
Stryker Instruments
Neurology · 184d
Cleared Jan 22, 2003
CANDELA SMOOTHBEAM LASER SYSTEM
K022884 · GEX
Candela Corp.
General & Plastic Surgery · 145d
Cleared Jan 22, 2003
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K023128 · HIS
Secure Scientific Sdn Bhd
Obstetrics & Gynecology · 125d
Cleared Jan 22, 2003
CONCERT CRANIOPLAST
K023575 · GXP
Immedica, Inc.
Neurology · 90d
Cleared Jan 22, 2003
SONICAID ONE
K023618 · HGM
Oxford Instruments Medical , Ltd.
Obstetrics & Gynecology · 85d
Cleared Jan 22, 2003
EXAJET
K023751 · ELW
GC America, Inc.
Dental · 75d
Cleared Jan 22, 2003
SYDNEY IVF EMBRYO BIOPSY MEDIUM
K023850 · MQL
Cook Ob/Gyn
Obstetrics & Gynecology · 64d
Cleared Jan 22, 2003
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
K023930 · MQE
CooperSurgical, Inc.
Obstetrics & Gynecology · 58d
Cleared Jan 22, 2003
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV...
K024177 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 35d
Cleared Jan 22, 2003
MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM
K024248 · KTT
Ebi, L.P.
Orthopedic · 30d
Cleared Jan 22, 2003
ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
K030064 · ITX
Sonosite,Inc.
Radiology · 15d
Cleared Jan 21, 2003
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
K010714 · FGE
Medi-Globe Corp.
Gastroenterology & Urology · 683d
Cleared Jan 21, 2003
BOUSSIGNAC C.P.A.P. DEVICE
K013884 · BYE
Vygon SA
Anesthesiology · 424d
Cleared Jan 21, 2003
COMPUMEDICS SOMTE SYSTEM
K021176 · MNR
Compumedics Limited
Anesthesiology · 284d
Cleared Jan 21, 2003
INNER-LOCK LOCKING INTRODUCER SHEATHS
K022170 · DYB
Rex Medical
Cardiovascular · 202d