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
72649–72672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 21, 2003
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI...
K023009 · DFH
The Binding Site, Ltd.
Immunology · 134d
Cleared Jan 21, 2003
FREELITE HUMAN LAMBDA FREE KIT
K023131 · DEH
The Binding Site, Ltd.
Immunology · 134d
Cleared Jan 21, 2003
UCC DENTAL MATERIAL
K023790 · EJT
Precious Chemicals U.S.A., Inc.
Dental · 69d
Cleared Jan 21, 2003
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000...
K023795 · JXN
Lin-Zhi International, Inc.
Toxicology · 69d
Cleared Jan 21, 2003
LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER...
K030074 · JIX
Cliniqa Corporation
Immunology · 13d
Cleared Jan 17, 2003
OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
K022035 · JEY
Osteomedics, Inc.
Dental · 210d
Cleared Jan 17, 2003
HYDROFERA BACTERIOSTATIC WOUND DRESSING
K023138 · FRO
Hydrofera, LLC
General & Plastic Surgery · 119d
Cleared Jan 17, 2003
NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
K023528 · JWH
Centerplus Orthopedics, Inc.
Orthopedic · 88d
Cleared Jan 17, 2003
LESSER METATARSAL PHALANGEAL JOINT IMPLANT
K023531 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 88d