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
87673–87696 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1998
ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05
K984325 · JJY
Bio-Rad
Immunology · 14d
Cleared Dec 17, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST...
K984347 · MID
Zeus Scientific, Inc.
Immunology · 13d
Cleared Dec 16, 1998
BRAUN PREFILLED SYRINGE
K970736 · FOZ
B.Braun Medical, Inc.
General Hospital · 656d
Cleared Dec 16, 1998
UNIPULSE CO2 SURGICAL LASER SYSTEM
K980475 · GEX
Nidek, Inc.
General & Plastic Surgery · 313d
Cleared Dec 16, 1998
IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT
K980637 · JWH
Implex Corp.
Orthopedic · 300d
Cleared Dec 16, 1998
DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION
K980925 · JWH
Howmedica Corp.
Orthopedic · 280d
Cleared Dec 16, 1998
DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION
K980926 · JDI
Howmedica Corp.
Orthopedic · 280d
Cleared Dec 16, 1998
LASEAWAY ALEXANDRITE LASER SYSTEM
K982316 · GEX
Silver Creek, Inc.
General & Plastic Surgery · 167d
Cleared Dec 16, 1998
AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
K982650 · CAC
Dideco S.P.A.
Anesthesiology · 139d
Cleared Dec 16, 1998
SPYROGEL HYDROGEL WOUND AND BURN DRESSING
K982804 · MGQ
Innovative Technologies (Us), Inc.
General & Plastic Surgery · 128d
Cleared Dec 16, 1998
I.V. EXTENSION SET OR I.V. ADMINISTRATION SET
K983073 · FPA
Integra Biotechnical, LLC
General Hospital · 105d
Cleared Dec 16, 1998
BIATAIN FOAM DRESSING
K983163 · FRO
Coloplast Corp.
General & Plastic Surgery · 97d
Cleared Dec 16, 1998
POLYMER THREADED ANCHOR
K983169 · MBI
Orthopaedic Biosystems, Ltd.
Orthopedic · 97d
Cleared Dec 16, 1998
BIATAIN FOAM ADHESIVE DRESSING
K983173 · FRO
Coloplast Corp.
General & Plastic Surgery · 97d
Cleared Dec 16, 1998
LIGHTSOURCE OR ILLUMINATOR MODEL I-100
K983277 · HBI
Cuda Products Co.
General & Plastic Surgery · 90d
Cleared Dec 16, 1998
AUTO SUTURE LAPAROSCOPES DEVICE
K983293 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 86d
Cleared Dec 16, 1998
MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102
K983331 · HCA
Medtronic PS Medical
Neurology · 85d
Cleared Dec 16, 1998
NU-GEL * WOUND DRESSING
K983362 · MGQ
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 83d
Cleared Dec 16, 1998
EVERBOND
K983414 · KLE
Espe Dental AG
Dental · 79d
Cleared Dec 16, 1998
PAIN CARE 2000
K983454 · MEB
Breg, Inc.
General Hospital · 77d
Cleared Dec 16, 1998
SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S...
K983495 · HWC
Syntec Scientific Corp.
Orthopedic · 72d
Cleared Dec 16, 1998
OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM
K983502 · LPH
Osteonics Corp.
Orthopedic · 71d
Cleared Dec 16, 1998
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
K983530 · KWP
Synthes (Usa)
Orthopedic · 69d
Cleared Dec 16, 1998
ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM
K983543 · GEX
Argus Photonics Group
General & Plastic Surgery · 68d