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
101569–101592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1995
MODEL INT/DL40I MICRO COMPUTER CONTROLLER FOR POWER WHEELCHAIRS
K950724 · ITI
Invacare Corp.
Physical Medicine · 172d
Cleared Aug 07, 1995
PRECISE HOSPITAL FOAM CLEANER DISINFECTANT
K951512 · LRJ
Caltech Industries, Inc.
General Hospital · 126d
Cleared Aug 07, 1995
REPLICA TOTAL HIP SYSTEM
K951741 · LPH
Osteo-Technology Intl., Inc.
Orthopedic · 129d
Cleared Aug 07, 1995
ELMER
K952118 · GEX
Biological Technology Corp.
General & Plastic Surgery · 94d
Cleared Aug 07, 1995
PROTOUCH OVERGLOVE
K952241 · MMP
Cottrell, Ltd.
General Hospital · 87d
Cleared Aug 07, 1995
THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA
K952278 · GCJ
General Surgical Innovations
General & Plastic Surgery · 84d
Cleared Aug 07, 1995
KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE
K952369 · BXB
Physicians Consulting, Inc.
Physical Medicine · 98d
Cleared Aug 07, 1995
MLI SET
K952392 · FPA
Medical Technologies of Georgia
General Hospital · 77d
Cleared Aug 07, 1995
REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM...
K952406 · KYZ
Contour Fabricators of Florida, Inc.
General Hospital · 77d
Cleared Aug 07, 1995
REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER
K952407 · KYZ
Contour Fabricators of Florida, Inc.
General Hospital · 77d
Cleared Aug 07, 1995
MAGNESIUM REAGENT
K952426 · JGJ
Schiapparelli Biosystems, Inc.
Chemistry · 75d
Cleared Aug 07, 1995
SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II...
K952444 · GCJ
Adjacent Surgical, Inc.
General & Plastic Surgery · 74d
Cleared Aug 07, 1995
TRANSAN, TRANSPARENT FILM DRESSING, TRANSPARENT WOUND DRSSING
K952449 · MGP
Medical Device Development Co.
General & Plastic Surgery · 74d
Cleared Aug 07, 1995
BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD
K952471 · MAI
Bioscience, Inc.
Orthopedic · 73d
Cleared Aug 07, 1995
SILON SILICONE TEXTILE COMPOSITE
K952546 · MDA
Bio Med Sciences, Inc.
General & Plastic Surgery · 66d
Cleared Aug 07, 1995
BIO-OSS
K952617 · LYC
Geistlich-Pharma
Dental · 62d
Cleared Aug 07, 1995
SOLUTION ADMINISTRATION SET
K952664 · FPA
Distronic Sterile Products, Inc.
General Hospital · 56d
Cleared Aug 07, 1995
ALANINE AMINOTRANSFERASE REAGENT SYSTEM
K952744 · CKA
Medical Diagnostic Technologies, Inc.
Chemistry · 52d
Cleared Aug 07, 1995
LACTATE DEHYDROGENASE REAGENT SYSTEM
K952747 · CFJ
Medical Diagnostic Technologies, Inc.
Chemistry · 52d
Cleared Aug 07, 1995
GOUVERNEUR AUDIGIER
K952758 · HQY
Ets Gouverneur-Audigier
Ophthalmic · 52d
Cleared Aug 07, 1995
EX-111 WOUND DRESSING
K952907 · FRO
Variseal Manufacturing Corp.
General & Plastic Surgery · 46d
Cleared Aug 07, 1995
ROYAL FLASH
K952939 · HQY
Royal Flash Enterprise Co. , Ltd.
Ophthalmic · 42d
Cleared Aug 07, 1995
SPI-SECRET PERSONAL INSTRUMENT CIC
K952986 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 40d
Cleared Aug 07, 1995
BIOACCESS MARROW HARVEST SYSTEM
K953064 · GDM
Bioaccess, Inc.
General & Plastic Surgery · 38d