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
88153–88176 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1998
FORTE, MODEL CPS ULTRASOUND
K982829 · IMI
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Nov 06, 1998
FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO
K982830 · IMG
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Nov 06, 1998
KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
K982837 · GWG
Karl Storz Endoscopy
Neurology · 86d
Cleared Nov 06, 1998
VINYL EXAMINATION GLOVES, POWDER FREE
K982933 · LYZ
General Gloves Corp.
General Hospital · 78d
Cleared Nov 06, 1998
XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT
K983025 · HRX
Xomed, Inc.
Orthopedic · 67d
Cleared Nov 06, 1998
TRITON HUDSON CHUCK ATTACHMENT
K983092 · HBB
Mednext, Inc.
Neurology · 64d
Cleared Nov 06, 1998
CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
K983141 · JDB
Johnson & Johnson Professionals, Inc.
Orthopedic · 59d
Cleared Nov 06, 1998
N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE
K983218 · FCG
Avid N.I.T., Inc.
Gastroenterology & Urology · 53d
Cleared Nov 06, 1998
VANCOMYCIN EIA ASSAY
K983280 · LEH
Diagnostic Reagents, Inc.
Toxicology · 49d
Cleared Nov 06, 1998
SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM
K983283 · MUH
Signet Radiology, Inc.
Radiology · 49d
Cleared Nov 06, 1998
QLICKSMART
K983367 · MMK
Handren Assoc.
General Hospital · 43d
Cleared Nov 06, 1998
ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50
K983405 · INI
Aceme Technologies Intl.
Physical Medicine · 39d
Cleared Nov 06, 1998
ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F
K983407 · INI
Aceme Technologies Intl.
Physical Medicine · 39d
Cleared Nov 06, 1998
BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY...
K983520 · ITI
Sunrise Medical, Inc.
Physical Medicine · 29d
Cleared Nov 06, 1998
MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING...
K983538 · GCJ
Solos Endoscopy, Inc.
General & Plastic Surgery · 28d
Cleared Nov 06, 1998
OCU-GUARD AND OCU-GUARD SUPPLE
K983581 · HQX
Bio-Vascular, Inc.
Ophthalmic · 24d
Cleared Nov 06, 1998
LOW PH PHENOLIC 256
K983585 · LRJ
Central Solutions, Inc.
General Hospital · 24d
Cleared Nov 06, 1998
SIEMENS SC 8000 BEDSIDE MONITOR
K983632 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 22d
Cleared Nov 06, 1998
QUICKIE G SERIES, MODEL G-424
K983677 · ITI
Sunrise Medical, Inc.
Physical Medicine · 18d
Cleared Nov 06, 1998
DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS
K983684 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 17d
Cleared Nov 05, 1998
INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS)
K980129 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 295d
Cleared Nov 05, 1998
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
K980756 · LKD
Ge Medical Systems Information...
Anesthesiology · 251d
Cleared Nov 05, 1998
POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
K981064 · LZA
P.T. Irama Dinamika Latex
General Hospital · 227d
Cleared Nov 05, 1998
CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT...
K982166 · GKZ
Coulter Corp.
Hematology · 139d