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
75265–75288 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2002
MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM
K021211 · GEH
Sanarus Medical, Inc.
General & Plastic Surgery · 70d
Cleared Jun 26, 2002
BELIMED STEAM STERILIZER, MODEL TOP 5000
K021223 · FLE
Sauter AG
General Hospital · 69d
Cleared Jun 26, 2002
SOFTLASE G2-SURGICAL DIODE LASER SYSTEM
K021227 · GEX
Zap Lasers, LLC
General & Plastic Surgery · 69d
Cleared Jun 26, 2002
WARMER 2000LD
K021289 · LHC
O.R. Solutions, Inc.
General Hospital · 64d
Cleared Jun 26, 2002
CONMED HEATWAVE HAND-CONTROLLED ELETRODE
K021299 · GEI
Conmedcorp
General & Plastic Surgery · 63d
Cleared Jun 26, 2002
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K021684 · JEY
Bioplate, Inc.
Orthopedic · 35d
Cleared Jun 26, 2002
AUTOPAL 50
K021733 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 29d
Cleared Jun 26, 2002
CRITERTION, MODEL #1067511
K021741 · EJT
Sterngold
Dental · 29d
Cleared Jun 26, 2002
T2 FEMORAL NAIL
K021744 · HSB
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jun 26, 2002
ENDIUS ATAVI SYSTEM
K021748 · HRX
Endius, Inc.
Orthopedic · 29d
Cleared Jun 26, 2002
CEMENTED FEMORAL HEAD RESURFING DEVICE
K021799 · KXA
Biomet Orthopedics, Inc.
Orthopedic · 26d
Cleared Jun 26, 2002
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
K021832 · HWC
Biomet, Inc.
Orthopedic · 22d
Cleared Jun 26, 2002
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)
K021879 · MNH
Depuyacromed
Orthopedic · 19d
Cleared Jun 26, 2002
CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)
K021880 · MNH
Depuyacromed
Orthopedic · 19d
Cleared Jun 25, 2002
UHI-3 HIGH FLOW INSUFFLATION UNIT
K014166 · HIF
Olympus Optical Co., Ltd.
Obstetrics & Gynecology · 188d
Cleared Jun 25, 2002
ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
K020296 · EWD
Apothecary Products, Inc.
Ear, Nose, Throat · 148d
Cleared Jun 25, 2002
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
K020985 · KNT
Tfx Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 25, 2002
BMN I TYPE MARROW ASPIRATION NEEDLE
K020987 · KNW
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 90d
Cleared Jun 25, 2002
LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
K021012 · HDY
Quality Medical Solusions, LLC
Obstetrics & Gynecology · 88d
Cleared Jun 25, 2002
TITANIUM CANNULATED INTERFERENCE SCREW
K021030 · HWC
Future Medical Systems, Inc.
Orthopedic · 88d
Cleared Jun 25, 2002
SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
K021241 · GKZ
Sysmex Corporation of America
Hematology · 67d
Cleared Jun 25, 2002
MODIFICATION TO PARA 5X
K021922 · JPK
Streck Laboratories, Inc.
Hematology · 14d
Cleared Jun 25, 2002
MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL
K021930 · JJY
Bionostics, Inc.
Chemistry · 13d
Cleared Jun 24, 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012623 · KTT
Alliance Medical Corp.
Orthopedic · 315d