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
86161–86184 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1999
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN...
K991299 · JHT
Princeton BioMeditech Corp.
Chemistry · 52d
Cleared May 28, 1999
SMARTPREP CENTRIFUGE SYSTEM
K991430 · JQC
Harvest Technologies, LLC
Hematology · 32d
Cleared May 28, 1999
QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED
K991462 · LYY
Latexx Partners Bhd.
General Hospital · 31d
Cleared May 28, 1999
INSURE PREGNANCY TEST
K991515 · DHA
Inbios Intl., Inc.
Chemistry · 28d
Cleared May 28, 1999
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
K991528 · MNH
Danek Medical, Inc.
Orthopedic · 25d
Cleared May 28, 1999
STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G
K991612 · MMK
Sterilogic Waste Systems, Inc.
General Hospital · 18d
Cleared May 28, 1999
HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES
K991640 · LZA
M.R.G. Industries Berhad
General Hospital · 16d
Cleared May 28, 1999
REUSABLE CONTOUR II NASAL MASK
K991648 · BZD
Respironics, Inc.
Anesthesiology · 15d
Cleared May 28, 1999
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K991661 · DQA
Siemens Medical Solutions USA, Inc.
Anesthesiology · 14d
Cleared May 27, 1999
CRIT-SCAN II MONITOR
K983551 · GKF
In-Line Diagnostics Corp.
Hematology · 230d
Cleared May 27, 1999
INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER
K983604 · MQF
Washington Regulatory Services
Obstetrics & Gynecology · 225d
Cleared May 27, 1999
NORMAL SALINE FLUSH SYRINGE
K984614 · FOZ
Rocap Div. of Sabratek Corp.
General Hospital · 149d
Cleared May 27, 1999
ELECTRODE NEEDLES
K990015 · IKT
Technomed Europe
Neurology · 143d
Cleared May 27, 1999
SURGISORB
K990432 · GAM
Sutures , Ltd.
General & Plastic Surgery · 105d
Cleared May 27, 1999
INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL...
K990663 · GCJ
Medtech , Ltd.
General & Plastic Surgery · 87d
Cleared May 27, 1999
ISOLOCK SPINAL SYSTEM
K990721 · MNH
Scien'Tx USA, Inc.
Orthopedic · 83d
Cleared May 27, 1999
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K990753 · JAQ
Cook, Inc.
Radiology · 80d
Cleared May 27, 1999
DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING
K990875 · MGP
Dermaphylyx, Inc.
General & Plastic Surgery · 72d
Cleared May 27, 1999
DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING
K990891 · FRO
Dermaphylyx, Inc.
General & Plastic Surgery · 71d
Cleared May 27, 1999
MODIFICATION OF MLT R694 RUBY LASER SYSTEM
K990902 · GEX
Medical Laser Technologies , Ltd.
General & Plastic Surgery · 70d
Cleared May 27, 1999
MILLENNIUM
K990908 · MXF
Endo Technic Corp.
Dental · 70d
Cleared May 27, 1999
E-SCAN
K990968 · LNH
Biosound Esaote, Inc.
Radiology · 65d
Cleared May 27, 1999
CHROMOPHARE D500, D530, D650
K991527 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 24d
Cleared May 27, 1999
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K991635 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 15d