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
87169–87192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 16, 1998
FUJINON EVL-F VIDEO LAPROSCOPE
K983561 · GCJ
Fujinon, Inc.
General & Plastic Surgery · 64d
Cleared Dec 16, 1998
HYSTEROSCOPIC GIFT CATHETER SETS
K983587 · MQF
Cook Ob/Gyn
Obstetrics & Gynecology · 64d
Cleared Dec 16, 1998
IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K983605 · LSR
Columbia Bioscience, Inc.
Microbiology · 63d
Cleared Dec 16, 1998
IS BORRELIA BURGDORFERI IGM TEST SYSTEM
K983606 · LSR
Columbia Bioscience, Inc.
Microbiology · 63d
Cleared Dec 16, 1998
COOK TEST TUBE HEATER
K983609 · MQG
Cook Ob/Gyn
Obstetrics & Gynecology · 63d
Cleared Dec 16, 1998
DYNA-LOK SPINAL SYSTEM
K983672 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 58d
Cleared Dec 16, 1998
LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580
K983807 · JJY
Bio-Rad
Immunology · 49d
Cleared Dec 16, 1998
MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE...
K983876 · EBI
Mycone Dental Supply Co., Inc. (A/K/A...
Dental · 44d
Cleared Dec 16, 1998
PEDIATRIC CANNULATED OSTEOTOMY PLATES
K983967 · HRS
Biomet, Inc.
Orthopedic · 40d