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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
40561–40584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2013
ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
K131199 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 34d
Cleared May 30, 2013
RAMPART O
K131216 · MAX
Spineology, Inc.
Orthopedic · 30d
Cleared May 30, 2013
FLASH AR PENTA / FLASH AR PENTA QUICK
K131404 · ELW
3M Deutschland GmbH
Dental · 15d
Cleared May 29, 2013
VASOSTAT HEMOSTASIS DEVICE
K123041 · DXC
Forge Medical, Inc.
Cardiovascular · 243d
Cleared May 29, 2013
FREND PSA PLUS (REAGENT CARTRIDGE)
K124056 · LTJ
Nanoentek, Inc.
Immunology · 149d
Cleared May 29, 2013
EXSPIRON 1XI
K130170 · BZK
Respiratory Motion, Inc.
Anesthesiology · 125d
Cleared May 29, 2013
MR PERMEABILITY
K130278 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 113d
Cleared May 29, 2013
STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE
K130288 · DSH
Cardiac Insight, Inc.
Cardiovascular · 113d
Cleared May 29, 2013
SCANORA 3DX
K130297 · OAS
Palodex Group OY
Radiology · 112d
Cleared May 29, 2013
MEDIENT MIDDLE TURBINATE IMPLANT
K130354 · LYA
Entrigue Surgical, Inc.
Ear, Nose, Throat · 106d
Cleared May 29, 2013
740 SELECT
K130411 · MWI
Cas Medical Systems, Inc.
Cardiovascular · 99d
Cleared May 29, 2013
ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
K131045 · DQK
Cardiac Designs, LLC
Cardiovascular · 44d
Cleared May 29, 2013
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K131121 · DXN
Health & Life Co., Ltd.
Cardiovascular · 37d
Cleared May 29, 2013
ADROIT GUIDING CATHETER
K131225 · DQY
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular · 29d
Cleared May 29, 2013
NIO COLOR 3MP LED
K131295 · LLZ
Barco N.V.
Radiology · 23d
Cleared May 29, 2013
ETIAM PACS COMPONENTS
K131392 · LLZ
Etiam S.A.S.U.
Radiology · 15d
Cleared May 28, 2013
VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
K123034 · GAR
Unilene Sac
General & Plastic Surgery · 242d
Cleared May 28, 2013
FINGER PULSE OXIMETER
K123801 · DQA
Shenzhen Kingyield Technology Co., Ltd.
Anesthesiology · 169d
Cleared May 28, 2013
CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS
K130343 · LZO
Corin USA
Orthopedic · 106d
Cleared May 24, 2013
POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND...
K121065 · DKZ
Polymed Therapeutics, Inc.
Toxicology · 413d
Cleared May 24, 2013
STAY FRESH SKIN FOLD MANAGEMENT TEXTILE
K121898 · FRL
Quick-Med Technologies, Inc.
General Hospital · 329d
Cleared May 24, 2013
SYNTHES SYNCAGE EVOLUTION SPACER
K122639 · MAX
Synthes USA Products, LLC
Orthopedic · 268d
Cleared May 24, 2013
PROVIDENCE CERVICAL CAGE
K122801 · ODP
Providence Medical Technology, Inc.
Orthopedic · 253d
Cleared May 24, 2013
ANTEGRADE FEMORAL NAIL
K123569 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 185d