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
101905–101928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1995
FILTERED EXTENSION SETS
K942988 · FPA
B. Braun of America, Inc.
General Hospital · 389d
Cleared Jul 14, 1995
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491
K944956 · LDF
The Heart Valve Div. Medtronic...
Cardiovascular · 280d
Cleared Jul 14, 1995
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K944957 · LDF
Medtronic Blood Systems, Inc.
Cardiovascular · 280d
Cleared Jul 14, 1995
UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492
K944966 · LDF
Medtronic Blood Systems, Inc.
Cardiovascular · 276d
Cleared Jul 14, 1995
CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160
K945296 · GWG
Clarus Medical Systems, Inc.
Neurology · 256d
Cleared Jul 14, 1995
VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE
K945592 · FMF
Vlv Associates, Inc.
General Hospital · 242d
Cleared Jul 14, 1995
BONE DRILL
K945706 · DZE
Osteo Implant Corp.
Dental · 235d
Cleared Jul 14, 1995
TE-800 PELVIC FLOOR EXERCISER
K945937 · HIR
Myo/Kinetic Systems, Inc.
Gastroenterology & Urology · 221d
Cleared Jul 14, 1995
1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES
K950154 · GWG
Neuro Navigational Corp.
Neurology · 178d
Cleared Jul 14, 1995
PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE
K951507 · GWQ
Neuroconcepts, Inc.
Neurology · 102d
Cleared Jul 14, 1995
GLUCOMETER ELITE M BLOOD GLUCOSE METER
K951537 · CGA
Bayer Corp.
Chemistry · 102d
Cleared Jul 14, 1995
SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM
K951605 · DSH
Spacelabs, Inc.
Cardiovascular · 98d
Cleared Jul 14, 1995
KIS-II IMPLANT FIXTURES
K951606 · DZE
Implant Center of the Palm Beaches
Dental · 106d
Cleared Jul 14, 1995
QUANTITATIVE EEG ANALYSIS SOFTWARE
K951724 · OLT
Neuroconcepts, Inc.
Neurology · 91d
Cleared Jul 14, 1995
REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT
K951843 · HRX
Future Medical Systems, Inc.
Orthopedic · 85d
Cleared Jul 14, 1995
ORGANIC TAMPONS
K951924 · HEB
Eco Yarn Co.
Obstetrics & Gynecology · 80d
Cleared Jul 14, 1995
CITATION MULTIPLE USE DELTA SCOPE
K951941 · HRX
Citation Medical Corp.
Orthopedic · 80d
Cleared Jul 14, 1995
AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q)
K952211 · JLW
Johnson & Johnson Clinical...
Chemistry · 64d
Cleared Jul 14, 1995
WELCH ALLYN FIBER OPTIC HEADLIGNT
K952289 · HPQ
Welch Allyn, Inc.
Ophthalmic · 59d
Cleared Jul 14, 1995
DRESSING CHANGE TRAY
K952334 · MCY
Busse Hospital Disposables, Inc.
General & Plastic Surgery · 57d
Cleared Jul 14, 1995
PRO-VENT, LINE DRAW, PULSATOR
K952516 · JKA
Smiths Industries Medical Systems, Inc.
Chemistry · 44d
Cleared Jul 14, 1995
RADIOLOGY PACKS
K952539 · LRO
Sterile Concepts, Inc.
General & Plastic Surgery · 44d
Cleared Jul 14, 1995
WATER JEL BURN KIT
K952561 · LRR
Water-Jel Technologies, Inc.
General & Plastic Surgery · 42d
Cleared Jul 14, 1995
60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2...
K952663 · FPK
Distronic Sterile Products, Inc.
General Hospital · 32d