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
89977–90000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1998
ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE,...
K974670 · EFB
Athena Technology, Inc.
Dental · 88d
Cleared Mar 13, 1998
MSI SURGICAL DRAPES
K974672 · KKX
Medical Specialty Innovations, Inc....
General Hospital · 88d
Cleared Mar 13, 1998
AESCULAP ABC CERVICAL PLATING SYSTEM
K974706 · KWQ
Aesculap, Inc.
Orthopedic · 87d
Cleared Mar 13, 1998
HOWMEDICA(R) FULLY THREADED SCREWS
K974720 · HSB
Howmedica, Inc.
Orthopedic · 85d
Cleared Mar 13, 1998
SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS...
K974749 · MNH
Cross Medical Products, Inc.
Orthopedic · 84d
Cleared Mar 13, 1998
HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE...
K974773 · DQX
Guidant Corp.
Cardiovascular · 81d
Cleared Mar 13, 1998
DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM
K974817 · DZL
Doctor'S Research Group, Inc.
Dental · 80d
Cleared Mar 13, 1998
LATEX EXAMINATION GLOVE POWDER FREE
K974870 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 74d
Cleared Mar 13, 1998
GAS MODULE II, MODEL 0998-00-0143
K974903 · CBS
Datascope Corp.
Anesthesiology · 72d
Cleared Mar 13, 1998
NITRILE PRE-POWDERED EXAMINATION GLOVES
K974907 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 72d
Cleared Mar 13, 1998
M500-100 SHARPS CONTAINER
K980003 · FMI
Imagination Medical, Inc.
General Hospital · 70d
Cleared Mar 13, 1998
SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES
K980071 · LYY
Supermax Latex Products Sdn. Bhd.
General Hospital · 64d
Cleared Mar 13, 1998
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL...
K980163 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 56d
Cleared Mar 13, 1998
POWDERFREE LATEX EXAMINATION GLOVES
K980167 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 56d
Cleared Mar 13, 1998
POWDERFREE LATEX EXAMINATION GLOVES
K980194 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 52d
Cleared Mar 13, 1998
LATEX EXAMINATION GLOVES
K980215 · LYY
P.T. Wantong Industry
General Hospital · 51d
Cleared Mar 13, 1998
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
K980249 · LFG
Princeton BioMeditech Corp.
Toxicology · 49d
Cleared Mar 13, 1998
POWDERFREE BLUE NITRILE EXAMINATION GLOVES (POLYMER COATED)
K980275 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 46d
Cleared Mar 13, 1998
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K980280 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 46d
Cleared Mar 13, 1998
POWDERFREE BLUE NITRILE EXAMINATION GLOVES
K980285 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 46d
Cleared Mar 13, 1998
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE
K980419 · LZA
Omnigrace (Thailand) , Ltd.
General Hospital · 38d
Cleared Mar 13, 1998
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED
K980421 · LZA
Omnigrace (Thailand) , Ltd.
General Hospital · 38d
Cleared Mar 13, 1998
NITRILE EXAMINATION GLOVES - POWDER FREE
K980511 · LZA
Influx Pacific Sdn. Bhd.
General Hospital · 31d
Cleared Mar 13, 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
K980572 · LYY
Hartalega Sdn Bhd
General Hospital · 24d