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
85417–85440 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1999
AB2 MED-FLO SOLUTION SET
K984569 · FPA
Ab2 Medical Products, Llp
General Hospital · 232d
Cleared Aug 12, 1999
DRAINAGE BAG
K990428 · EXF
Remington Medical, Inc.
Gastroenterology & Urology · 182d
Cleared Aug 12, 1999
GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE
K990440 · MGQ
Gentell
General & Plastic Surgery · 182d
Cleared Aug 12, 1999
REMOTE INTRODUCER, MODEL PI-1000
K990907 · HAW
Image-Guided Neurologics, Inc.
Neurology · 147d
Cleared Aug 12, 1999
PMS 750 FINGERSWITCH
K991669 · GEI
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 90d
Cleared Aug 12, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM,...
K991674 · FGE
Cordis Corp.
Gastroenterology & Urology · 87d
Cleared Aug 12, 1999
WHITESIDE BIOMECHANICS SPINAL SYSTEM
K991678 · KWQ
Whiteside Biomechanics, Inc.
Orthopedic · 87d
Cleared Aug 12, 1999
OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM,...
K991718 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 84d
Cleared Aug 12, 1999
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
K991757 · EFQ
Furlong Industries
General & Plastic Surgery · 80d
Cleared Aug 12, 1999
SOUND VASER SYSTEM
K991791 · LFL
Sound Surgical Technologies, LLC
General & Plastic Surgery · 79d
Cleared Aug 12, 1999
CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE
K991792 · GEH
Influence, Inc.
General & Plastic Surgery · 78d
Cleared Aug 12, 1999
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT...
K991820 · LYR
Zeus Scientific, Inc.
Microbiology · 77d
Cleared Aug 12, 1999
ULTIMAX HAIG II NAIL SYSTEM
K991889 · LXT
Encore Orthopedics, Inc.
Orthopedic · 70d
Cleared Aug 12, 1999
RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
K991895 · HHK
Ri Mos. S.R.L.
Obstetrics & Gynecology · 70d
Cleared Aug 12, 1999
DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
K991920 · KMF
Dermaphylyx, Inc.
General & Plastic Surgery · 66d
Cleared Aug 12, 1999
CTD MARK I TRACTION DEVICE
K991931 · ITH
Therasys, Inc.
Physical Medicine · 65d
Cleared Aug 12, 1999
LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)
K991949 · KGO
La Glove (M) Sdn. Bhd.
General Hospital · 64d
Cleared Aug 12, 1999
LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
K991950 · KGO
La Glove (M) Sdn. Bhd.
General Hospital · 64d
Cleared Aug 12, 1999
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
K992029 · LBR
Elan Diagnostics
Chemistry · 57d
Cleared Aug 12, 1999
MANUAL WHEELCHAIR
K992035 · IOR
Major Mobility Products, Inc.
Physical Medicine · 57d
Cleared Aug 12, 1999
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
K992052 · INI
Invacare Corp.
Physical Medicine · 55d
Cleared Aug 12, 1999
ENCORE FULLY COATED HIP
K992109 · LPH
Encore Orthopedics, Inc.
Orthopedic · 51d
Cleared Aug 12, 1999
KINEMATIC II ROTATING HINGE KNEE
K992346 · LGE
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Aug 12, 1999
SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN
K992363 · FRO
Euromed, Inc.
General & Plastic Surgery · 28d