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
86401–86424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1999
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280
K981431 · DXN
Panasonic Corporation (Panasonic)
Cardiovascular · 317d
Cleared Mar 03, 1999
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284
K981542 · DXN
Panasonic Corporation (Panasonic)
Cardiovascular · 308d
Cleared Mar 03, 1999
STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)
K981947 · KGO
Boston Medical Corp.
General Hospital · 273d
Cleared Mar 03, 1999
GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38
K983075 · FGE
Guidant Corp.
Gastroenterology & Urology · 182d
Cleared Mar 03, 1999
D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
K983797 · HQE
Dutch Ophthalmic USA, Inc.
Ophthalmic · 126d
Cleared Mar 03, 1999
MEPITEL NON ADHERENT SILICONE DRESSING
K984371 · MGP
Molnlycke Health Care, Inc.
General & Plastic Surgery · 86d
Cleared Mar 03, 1999
HA ABSORBENT WOUND DRESSING
K984388 · KGN
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 85d
Cleared Mar 03, 1999
TOPOGRAPHIC IMAGING MARKER
K990242 · KPR
I.Z.I. Medical Products Corp.
Radiology · 37d
Cleared Mar 03, 1999
TOPOGRAPHIC IMAGING MARKER
K990298 · KPR
I.Z.I. Medical Products Corp.
Radiology · 30d
Cleared Mar 03, 1999
HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
K990306 · EBC
Kay See Dental Mfg. Co.
Dental · 30d
Cleared Mar 02, 1999
ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL
K964235 · DXN
Industrielle Entwicklung...
Cardiovascular · 860d
Cleared Mar 02, 1999
PHORESOR II,MODEL PM900
K982668 · EGJ
Iomed, Inc.
Physical Medicine · 214d
Cleared Mar 02, 1999
DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
K984322 · DTP
Dideco S.P.A.
Cardiovascular · 89d
Cleared Mar 02, 1999
SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100,...
K984364 · KTT
Syntec Scientific Corp.
Orthopedic · 85d
Cleared Mar 02, 1999
MOSS TUBES, INC. NASAL TUBE - MARK IV
K984629 · BSS
Moss Tubes, Inc.
Gastroenterology & Urology · 62d
Cleared Mar 02, 1999
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE
K990131 · MQV
Interpore Cross Intl.
Orthopedic · 47d
Cleared Mar 02, 1999
SSA-320A JUST VISION 200/ SSA-325A JUST VISION
K990490 · IYO
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Mar 01, 1999
TUTODROP 1 AND TUTODROP 2
K982098 · FPA
Myco Medical Supplies, Inc.
General Hospital · 259d
Cleared Mar 01, 1999
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
K982738 · HIH
Gynecare, Inc.
Obstetrics & Gynecology · 207d
Cleared Mar 01, 1999
FIXATION SYSTEM
K983318 · GDW
General Surgical Innovations
General & Plastic Surgery · 161d
Cleared Mar 01, 1999
BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES
K983476 · KNT
Navion Biomedical Corp.
Gastroenterology & Urology · 150d
Cleared Mar 01, 1999
VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE
K983790 · LCM
Sun Biomedical Laboratories, Inc.
Toxicology · 125d
Cleared Mar 01, 1999
BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)
K983817 · CAH
King Systems Corp.
General Hospital · 123d
Cleared Mar 01, 1999
PROVISIONAL DENTAL IMPLANT SYSTEM
K984287 · DZE
Nobel Biocare Uas, Inc.
Dental · 90d