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
78697–78720 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2001
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
K011976 · JWH
Exactech, Inc.
Orthopedic · 21d
Cleared Jul 13, 2001
METAL TRANSCEND ARTICULATION SYSTEM
K004043 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 196d
Cleared Jul 13, 2001
POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
K010051 · JDR
Xiros Plc
Orthopedic · 186d
Cleared Jul 13, 2001
SUPREMA POWERED WHEELCHAIR
K010600 · ITI
Luigi Chinetti
Physical Medicine · 135d
Cleared Jul 13, 2001
MALLEABLE SHAFT CLAMP
K011078 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 95d
Cleared Jul 13, 2001
ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)
K011257 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 80d
Cleared Jul 13, 2001
RAMBLER
K011401 · INI
Rambler Mobility, Inc.
Physical Medicine · 67d
Cleared Jul 13, 2001
MODEL 100 ACTIVITY MONITOR
K011429 · GYD
Telecom Medical, Inc.
Neurology · 65d
Cleared Jul 13, 2001
MEDLINE GROUNDING PAD
K011515 · JOS
Medline Industries, Inc.
General & Plastic Surgery · 57d
Cleared Jul 13, 2001
AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM
K011779 · DXN
Avid Care Corp.
Cardiovascular · 36d
Cleared Jul 13, 2001
LIFECARD CF 7 DAY
K011837 · MWJ
Reynolds Medical , Ltd.
Cardiovascular · 31d
Cleared Jul 13, 2001
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
K011847 · DRF
Zynergy Cardio Vasular (Zcv), Inc.
Cardiovascular · 30d
Cleared Jul 13, 2001
IN-FAST BONE SCREW SYSTEM
K011910 · HWC
American Medical Systems, Inc.
Orthopedic · 24d
Cleared Jul 13, 2001
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
K011942 · HSD
Tornier
Orthopedic · 22d
Cleared Jul 13, 2001
HOFFMAN II HYBRID RING CLAMP
K011948 · LXT
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 18d
Cleared Jul 13, 2001
QUANTUM BLAST
K011993 · ITI
Pride Mobility Products Corp.
Physical Medicine · 17d
Cleared Jul 13, 2001
MEDICAL DEPOT POWER NEB 1
K012006 · CAF
Medical Depot, Inc.
Anesthesiology · 16d
Cleared Jul 13, 2001
LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
K012013 · DXN
A&D Engineering, Inc.
Cardiovascular · 15d
Cleared Jul 12, 2001
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
K000265 · JOL
Primary Care Solutions, Inc.
General Hospital · 531d
Cleared Jul 12, 2001
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
K000266 · JOL
Primary Care Solutions, Inc.
General Hospital · 531d
Cleared Jul 12, 2001
HA-TI (HAND TITANIUM SCREW) IMPLANT
K003045 · DZE
Hati Dental Ag.
Dental · 286d
Cleared Jul 12, 2001
IMMOBILIZATION SYSTEM FOR ENT
K003779 · IYE
Arplay Medical S.A.
Radiology · 217d
Cleared Jul 12, 2001
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K003954 · MQV
Biocomposites, Ltd.
Orthopedic · 203d