Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
152665–152688 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 1984
IMPULS 3, IT SELECTOR
K842805 · ISB
Robert Bosch Corp.
Physical Medicine · 15d
Cleared Jul 31, 1984
CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE
K832290 · KNX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 384d
Cleared Jul 31, 1984
MONOXYCHLOROSENE WAREXIN
K834455 · FKQ
Guardian Chemical
Gastroenterology & Urology · 225d
Cleared Jul 31, 1984
GASTROINTESTINAL DILATOR
K841310 · KNQ
Thomas J. Fogarty, M.D.
Gastroenterology & Urology · 123d
Cleared Jul 31, 1984
VAGINAL SPECULUM - DISPOSABLE
K841909 · HIB
Galenica Enterprises, Inc.
Obstetrics & Gynecology · 83d
Cleared Jul 31, 1984
PACKETS FOR THE PREP OF DIALYSATES &
K842154 · FKQ
Organon Teknika Corp.
Gastroenterology & Urology · 62d
Cleared Jul 31, 1984
PROTEX CONTRACEPT PLUS W/SPERM-LUB
K842185 · HIS
National Sanitary Laboratories, Inc.
Obstetrics & Gynecology · 60d
Cleared Jul 31, 1984
NATURA-TONE OR LUXOPAL CL ACRYLIC
K842208 · ELM
Parexel Intl. Corp.
Dental · 57d
Cleared Jul 31, 1984
CROWN INDEX TRAY
K842273 · EHY
Di-Equi Dental Products
Dental · 53d
Cleared Jul 31, 1984
F-G-P TRAY
K842274 · EHY
Di-Equi Dental Products
Dental · 53d
Cleared Jul 31, 1984
ISOLIGHT
K842358 · EBA
Planmeca USA, Inc.
Dental · 39d
Cleared Jul 31, 1984
MS NONPRECIOUS CROWN & BRIDGE ALLOY
K842377 · EJH
Dental Ventures of America, Inc.
Dental · 43d
Cleared Jul 30, 1984
COOK PACEMAKER CORP. 116 BIOPOLAR CARDI
K843001
Cook Pacemaker Corp.
Cardiovascular
Cleared Jul 28, 1984
INFRA-EYE 160
K841271 · LHQ
Fujitsu , Ltd.
Radiology · 123d
Cleared Jul 27, 1984
MONITOR ONE
K841172 · DSI
Qmed, Inc.
Cardiovascular · 130d
Cleared Jul 27, 1984
SUNGLASSES
K841248 · HQG
China Toy & Novelty Co., Ltd.
Ophthalmic · 150d
Cleared Jul 27, 1984
REDO CENTRAL VENOUS CATHETER-NEONATE
K841443 · LJS
Intl. Hospital Products, Inc.
General Hospital · 112d
Cleared Jul 27, 1984
PARA-TEK
K841531 · JPK
Streck Laboratories, Inc.
Hematology · 102d
Cleared Jul 27, 1984
KEYMED SIGMOIDOSCOPE SUCTION UNIT
K841822 · DRM
Keymed, Inc.
Cardiovascular · 86d
Cleared Jul 27, 1984
ENTEROPORT NUTRITION PUMP
K841827 · FRN
Diatek, Inc.
General Hospital · 85d
Cleared Jul 27, 1984
ARM-A-VIAL LV STERIAL WATER FOR INHALA
K841987 · CCQ
Armour Pharmaceutical Co.
Anesthesiology · 86d
Cleared Jul 27, 1984
ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT
K841988 · CCQ
Armour Pharmaceutical Co.
Anesthesiology · 79d
Cleared Jul 27, 1984
ARM-A-VIAL LV SODIUM CHLORIDE INHALAT
K841989 · CCQ
Armour Pharmaceutical Co.
Anesthesiology · 79d
Cleared Jul 27, 1984
ARM-A-CARE NEBULIZER-NEBULIZER
K841990 · CCQ
Armour Pharmaceutical Co.
Anesthesiology · 79d