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
75169–75192 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2002
MAC-LAB/CARDIOLAB EP/COMBOLAB
K021366 · DQK
General Electric Medical Systems...
Cardiovascular · 64d
Cleared Jul 03, 2002
COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES
K021407 · FZP
Coalescent Surgical
General & Plastic Surgery · 61d
Cleared Jul 03, 2002
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
K021453 · MKJ
Philips Medical Systems
Cardiovascular · 58d
Cleared Jul 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021827 · NBW
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Jul 03, 2002
SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05,...
K021919 · KWP
Ortho Tec, LLC
Orthopedic · 22d
Cleared Jul 03, 2002
TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM...
K021958 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 19d
Cleared Jul 02, 2002
CRANIAL STEREOTACTIC EQUIPMENT
K010065 · IYE
Arplay Medical S.A.
Radiology · 540d
Cleared Jul 02, 2002
MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
K013205 · DRQ
Millar Instruments, Inc.
Cardiovascular · 280d
Cleared Jul 02, 2002
RE-ENTRANT CHAMBER
K013689 · KPT
Sun Nuclear Corp.
Radiology · 238d
Cleared Jul 02, 2002
SSIR SYSTEM
K014208 · ILY
Russian-American Technology...
Physical Medicine · 193d
Cleared Jul 02, 2002
DINAMAP PROCARE SERIES MONITOR
K014255 · MWI
Ge Medical Systems Information...
Cardiovascular · 188d
Cleared Jul 02, 2002
LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
K020021 · GEX
Laserscope
General & Plastic Surgery · 180d
Cleared Jul 02, 2002
INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
K020386 · CAW
Invacare Corp.
Anesthesiology · 146d
Cleared Jul 02, 2002
RESPERATE
K020399 · HCC
Intercure , Ltd.
Neurology · 146d
Cleared Jul 02, 2002
ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
K021124 · IYE
Wfr/Aquaplast Corp.
Radiology · 85d
Cleared Jul 02, 2002
D/SENSE 1-STEP
K021146 · EJK
Centrix, Inc.
Dental · 84d
Cleared Jul 02, 2002
CANDELA VBEAM PULSED DYE LASER SYSTEM
K021180 · GEX
Candela Corp.
General & Plastic Surgery · 78d
Cleared Jul 02, 2002
SCEPTRE-VS
K021314 · LLZ
Hitachi Medical Systems America, Inc.
Radiology · 68d
Cleared Jul 02, 2002
XIVE DENTAL IMPLANT SYSTEM
K021318 · DZE
Friadent GmbH
Dental · 68d
Cleared Jul 02, 2002
STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
K021346 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Jul 02, 2002
AART CHIN IMPLANT
K021417 · FWP
Aesthetic and Reconstructive...
General & Plastic Surgery · 60d
Cleared Jul 02, 2002
AART NASAL IMPLANT
K021418 · FZE
Aesthetic and Reconstructive...
General & Plastic Surgery · 60d
Cleared Jul 02, 2002
AART MALAR IMPLANT
K021419 · LZK
Aesthetic and Reconstructive...
General & Plastic Surgery · 60d
Cleared Jul 02, 2002
STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN...
K021521 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 53d