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
87649–87672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 05, 1998
H-RAY
K982720 · LYZ
Shijiazhuang Hongray Plastic Products...
General Hospital · 93d
Cleared Nov 05, 1998
MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7
K982821 · MUJ
Multimedia Medical Systems, Inc.
Radiology · 86d
Cleared Nov 05, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
K983151 · KXT
Beckman Coulter, Inc.
Toxicology · 57d
Cleared Nov 05, 1998
DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
K983159 · DKB
Diagnostic Reagents, Inc.
Toxicology · 57d
Cleared Nov 05, 1998
MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
K983287 · MKJ
Graphic Controls Corp.
Cardiovascular · 48d
Cleared Nov 05, 1998
VINYL EXAM GLOVES, POWDER FREE
K983494 · LYZ
Glormed Intl., Inc.
General Hospital · 31d
Cleared Nov 05, 1998
EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM...
K983608 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 22d
Cleared Nov 05, 1998
POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES
K983612 · LYZ
Shanghai Jiatai Plastic Products Co.,...
General Hospital · 22d
Cleared Nov 04, 1998
BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)
K971616 · DQO
Data Sciences Intl., Inc.
Cardiovascular · 551d