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
40633–40656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 2013
3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL
K130457 · MOS
Resonance Innovations, LLC
Radiology · 87d
Cleared May 20, 2013
AIGIS RX R PM/ AIGIS RX R ICD
K130943 · FTL
Tyrx, Inc.
General & Plastic Surgery · 46d
Cleared May 17, 2013
DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
K120671 · FLL
Cotronic Technology Limited
General Hospital · 438d
Cleared May 17, 2013
HUMAN IGG CSF KIT
K120749 · CFN
The Binding Site Group , Ltd.
Immunology · 431d
Cleared May 17, 2013
HUMAN IGM CSF KIT
K120750 · CFN
The Binding Site Group , Ltd.
Immunology · 431d
Cleared May 17, 2013
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
K121976 · MPN
Aesculap, Inc.
General & Plastic Surgery · 316d
Cleared May 17, 2013
SCOPEVALET DISPOSABLE BIOPSY VALVE
K122417 · OCX
The Ruhof Corp.
Gastroenterology & Urology · 282d
Cleared May 17, 2013
TRYOUT-VPS HOLDING PASTE
K122974 · EMA
Crown Delta Corp.
Dental · 233d
Cleared May 17, 2013
NEODENT IMPLANT SYSTEM
K123022 · DZE
Jjgc Industria E Comercio DE...
Dental · 231d
Cleared May 17, 2013
MAGNETOM SKYRA
K123510 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 185d
Cleared May 17, 2013
OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
K123603 · OXO
Ge Healthcare Surgery GE Oec Medical...
Radiology · 177d
Cleared May 17, 2013
AIO HD OTOSCOPE
K123821 · ERA
Blue Focus
Ear, Nose, Throat · 156d
Cleared May 17, 2013
MECTALIF ANTERIOR
K124034 · OVD
Medacta International
Orthopedic · 140d
Cleared May 17, 2013
THE VAULT SYSTEM
K124051 · LLZ
Somersault Orthopedics, Inc.
Radiology · 137d
Cleared May 17, 2013
BREATHE CPAP SYSTEM
K130037 · BZD
Breathe Technologies, Inc.
Anesthesiology · 130d
Cleared May 17, 2013
RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS...
K130105 · HTY
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 122d
Cleared May 17, 2013
KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
K130377 · MQB
Medicatech USA
Radiology · 92d
Cleared May 17, 2013
NEUROQ 3.6
K130451 · KPS
Syntermed, Inc.
Radiology · 84d
Cleared May 17, 2013
SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
K130533 · HSN
Tornier S.A.S.
Orthopedic · 77d
Cleared May 17, 2013
SOMNODENT HERBST
K130558 · LRK
Somnomed, Inc.
Dental · 74d
Cleared May 17, 2013
XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML
K130647 · ELW
Heraeus Kulzer, LLC
Dental · 67d
Cleared May 17, 2013
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
K130885 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared May 17, 2013
ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
K130922 · OLI
Erchonia Medical, Inc.
General & Plastic Surgery · 44d
Cleared May 16, 2013
PORTABLE X-RAY SYSTEM
K122124 · EHD
Osstem Implant Co., Ltd.
Radiology · 302d