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
85657–85680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 27, 1999
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
K991703 · GCJ
Stryker Instruments
General & Plastic Surgery · 8d
Cleared May 26, 1999
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER...
K981246 · JXG
Integra Neurocare, LLC
Neurology · 415d
Cleared May 26, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN...
K983805 · LFX
Zeus Scientific, Inc.
Microbiology · 210d
Cleared May 26, 1999
THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN...
K984120 · GQL
Zeus Scientific, Inc.
Microbiology · 189d
Cleared May 26, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN...
K984135 · GQL
Zeus Scientific, Inc.
Microbiology · 189d
Cleared May 26, 1999
DIGI-SNAP
K984169 · MNR
Snap Laboratories, LLC
Anesthesiology · 187d
Cleared May 26, 1999
TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201
K984497 · FLL
Oriental System Technology, Inc.
General Hospital · 160d
Cleared May 26, 1999
QUANTEC-E ENDO SYSTEM
K990739 · EKX
Sybron Dental Specialties, Inc.
Dental · 82d
Cleared May 26, 1999
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
K990963 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 64d