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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
150841–150864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1984
SPACELABS ALPHA PC PATIENT COMPUTER
K842616 · DSI
Spacelabs, Inc.
Cardiovascular · 105d
Cleared Oct 18, 1984
LIFEPAK 8
K842624 · LDD
Physio-Control Corp.
Cardiovascular · 105d
Cleared Oct 18, 1984
INFRARED COAGULATOR
K842810 · KNS
Endo Lase, Inc.
Gastroenterology & Urology · 92d
Cleared Oct 18, 1984
HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS
K842829 · DTL
North American Instrument Corp.
Cardiovascular · 90d
Cleared Oct 18, 1984
EXTENDED LIFE CAPD SOLUTION TRANSFER
K842885 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 87d
Cleared Oct 18, 1984
EMA FREEGENOL DENTAL CEMENT
K842994 · EMA
Int'L Corp.
Dental · 80d
Cleared Oct 18, 1984
FRESENIUS HAEMODIALYSIS A2008
K843014 · KDI
Seratronics, Inc.
Hematology · 79d
Cleared Oct 18, 1984
TWO COMPONENT RTV VINYL SILICONE MATER
K843145 · ELW
Crown Delta Corp.
Dental · 69d
Cleared Oct 18, 1984
LIFEPAK 200
K843229 · LDD
Physio-Control Corp.
Cardiovascular · 62d
Cleared Oct 18, 1984
ARRHYTHMIA CENTRAL OCC-7101
K843287 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 58d
Cleared Oct 18, 1984
FLOW-DIRECTED THERMODILUTION CATH
K843409 · DYG
Andover Medical, Inc.
Cardiovascular · 48d
Cleared Oct 18, 1984
THERMAL DILUTION CATHETER
K843411 · DYG
Andover Medical, Inc.
Cardiovascular · 48d
Cleared Oct 18, 1984
ARGYLE SILICONE LEFT VENTRICULAR AND
K843444 · DWF
Sherwood Medical Co.
Cardiovascular · 43d
Cleared Oct 18, 1984
PHARMA-PLAST CONNECTING TUBE TYPE URIN-
K843481 · KNX
Zimmar Consulting , Ltd.
Gastroenterology & Urology · 42d
Cleared Oct 18, 1984
FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN
K843500 · DYB
Cardio-Vascular Innovations, Inc.
Cardiovascular · 42d
Cleared Oct 18, 1984
AMER. BENTLEY HEMOFILTER HOLDER HFH-1
K843504 · FKI
American Bentley
Gastroenterology & Urology · 42d
Cleared Oct 18, 1984
ORTHOMITE 111 ADHESIVE
K843527 · DYH
Rocky Mountain Orthodontics, Inc.
Dental · 41d
Cleared Oct 18, 1984
PO 2 LYTRODE
K843538 · DRY
Polystan C/O Vitalcor, Inc.
Cardiovascular · 41d
Cleared Oct 18, 1984
SHILEY CORONARY CARDIOPLEGIA ADAPTOR
K843542 · DWF
Shiley, Inc.
Cardiovascular · 41d
Cleared Oct 18, 1984
HOLLOW FIBER DIALYZER
K843632 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 31d
Cleared Oct 18, 1984
SINGLE WALL INTRODUCER NEEDLE
K843719 · DYB
Ocean Medical Products, Ltd.
Cardiovascular · 24d
Cleared Oct 18, 1984
NAMIC ADB ANGIOGRAPHIC DUMP BAG
K843726 · DQO
North American Instrument Corp.
Cardiovascular · 24d
Cleared Oct 18, 1984
VAPOR-PHASE HUMIDIFIER SYS-ADVANCED
K843932 · BTT
Inspiron Corp.
Anesthesiology · 13d
Cleared Oct 18, 1984
OHMEDA ANESTHESIA RECORD KEEPER
K844012 · BSZ
Ohmeda Medical
Anesthesiology · 6d