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
144625–144648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1986
HPS II SMOOTH STEM
K860701 · JDI
Depuy, Inc.
Orthopedic · 22d
Cleared Mar 19, 1986
MEDIUM CONCENTRATION OXYGEN MASKS
K860869 · BYG
Dhd Medical Products Div. Diemolding...
Anesthesiology · 22d
Cleared Mar 19, 1986
AEROSOL MASKS/ADULT & PAEDIATRIC
K860870 · BYG
Dhd Medical Products Div. Diemolding...
Anesthesiology · 22d
Cleared Mar 19, 1986
TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC
K860871 · BYG
Dhd Medical Products Div. Diemolding...
Anesthesiology · 22d
Cleared Mar 19, 1986
NASAL CANNULA W/2M & 5M TUBING
K860872 · CAT
Dhd Medical Products Div. Diemolding...
Anesthesiology · 22d
Cleared Mar 19, 1986
VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC
K860874 · BYF
Dhd Medical Products Div. Diemolding...
Anesthesiology · 22d
Cleared Mar 19, 1986
CATHETER MOUNTS & ELBOWS (VARIOUS TYPES)
K860881 · BZA
Dhd Medical Products Div. Diemolding...
Anesthesiology · 22d
Cleared Mar 19, 1986
SELF-SEALING WATER TRAP/ADULT/PAEDIATRIC CIRCUITS
K860883 · BYH
Dhd Medical Products Div. Diemolding...
Anesthesiology · 22d
Cleared Mar 19, 1986
SELF-SEALING WATER TRAP/ACCESSORIES
K860884 · BYH
Dhd Medical Products Div. Diemolding...
Anesthesiology · 22d
Cleared Mar 19, 1986
STRAIGHT CONNECTORS, 22MM
K860886 · BZA
Dhd Medical Products Div. Diemolding...
Anesthesiology · 22d
Cleared Mar 19, 1986
T-PIECES CONNECTORS
K860887 · BZA
Dhd Medical Products Div. Diemolding...
Anesthesiology · 22d
Cleared Mar 19, 1986
CONNECTORS/VALVE INSERT
K860888 · BZA
Dhd Medical Products Div. Diemolding...
Anesthesiology · 22d
Cleared Mar 18, 1986
STERISTORAGE CONTAINER
K853450 · FMF
K-Seven Industries, Inc.
General Hospital · 214d
Cleared Mar 18, 1986
HEPARIN MICRO-INFUSOR
K853664 · FRN
Y
General Hospital · 196d
Cleared Mar 18, 1986
SIMULATOR
K854265 · JQP
Cygnus of South Florida, Inc.
General Hospital · 146d
Cleared Mar 18, 1986
LIFEPORT AMBULATORY INFUSION PUMP
K854318 · FRN
Strato Medical Corp.
General Hospital · 141d
Cleared Mar 18, 1986
DIFCO STREP A LATEX TEST
K854978 · GTZ
Difco Laboratories, Inc.
Microbiology · 96d
Cleared Mar 18, 1986
THE WOOD PUMP 'OLE RED'
K855054 · KZD
T.C. Retigo, Inc.
General Hospital · 91d
Cleared Mar 18, 1986
PRESSURE INFUSOR #1900
K860084 · KZD
Pa Medical Corp.
General Hospital · 68d
Cleared Mar 18, 1986
SOLUTION ADMINISTRATION SETS
K860272 · FPA
Travenol Laboratories, S.A.
General Hospital · 50d
Cleared Mar 18, 1986
VIAPIC CENTRAL LINE CATHETER
K860290 · FOZ
Parke-Davis Co.
General Hospital · 49d
Cleared Mar 18, 1986
UNICADDY I & II I.V. CONTAINER CADDY IMS POLE MATE
K860468 · FOX
Intl. Medication Systems, Ltd.
General Hospital · 40d
Cleared Mar 18, 1986
F.M. WEIST,KG (URODYNAMIC SYSTEMS)
K860571 · FAP
F.M. Wiest USA, Inc.
Gastroenterology & Urology · 32d
Cleared Mar 18, 1986
VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA
K860751 · JPK
Bio/Data Corp.
Hematology · 18d