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
154153–154176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1984
INTRAVENOUS FILTER SET
K834130 · FPA
Tri-Med, Inc.
General Hospital · 77d
Cleared Jan 30, 1984
FLEXXR* CPM SYSTEM
K834203 · BXB
Qarex Laboratories, Inc.
Physical Medicine · 56d
Cleared Jan 30, 1984
PARALLEL FLAME PHOTOMETER & SODIUM
K834248 · JGT
American Monitor Corp.
Chemistry · 54d
Cleared Jan 30, 1984
CARDIODATA PACE RECORDER
K834257 · DSH
Cardio Data
Cardiovascular · 54d
Cleared Jan 30, 1984
LIQUI-URA TOXIC URINE CONTROL
K834259 · DIF
Biodiagnostic Intl
Toxicology · 54d
Cleared Jan 30, 1984
CONTINU-FLO SOLUTION ADMIN. 2C9102
K834289 · FPA
Travenol Laboratories, S.A.
General Hospital · 53d
Cleared Jan 30, 1984
MODULAR EXTREMITY CASTING SUPPORT
K834384 · LGG
Buckman Co., Inc.
Orthopedic · 47d
Cleared Jan 30, 1984
INFUSION PUMP PRIMER
K834461 · FRN
Parker Hannifin Corp.
General Hospital · 42d
Cleared Jan 30, 1984
TRAIL CHAIR
K834498 · IQC
Winchester Industries, Inc.
Physical Medicine · 41d
Cleared Jan 30, 1984
PACESAVER & SCOUT
K834506 · INI
Burke, Inc.
Physical Medicine · 40d
Cleared Jan 30, 1984
CALMTONE
K834519 · HCC
Thought Technology , Ltd.
Neurology · 40d
Cleared Jan 30, 1984
THROMBO PLUS
K834527 · GGK
W. Sarstedt, Inc.
Hematology · 40d
Cleared Jan 30, 1984
ELECTRODE LEAD CONSTRUCTION
K834533 · DTB
Telectronics, Inc.
Cardiovascular · 39d
Cleared Jan 30, 1984
PREMIER
K834552 · ITI
Everest & Jennings, Inc.
Physical Medicine · 34d
Cleared Jan 30, 1984
EGERTON TURNING & TILTING BED
K834563 · IKZ
Kinetic Concepts, Inc.
Physical Medicine · 33d
Cleared Jan 30, 1984
CLEAR LEADS-RADIOTRANSPARENT WIRES
K834583 · IKD
Quinton, Inc.
Physical Medicine · 32d
Cleared Jan 30, 1984
TRANSFERRIN, ANTIGEN, ANTIBODY, CONTROL
K834603
Technicon Instruments Corp.
Immunology · 122d
Cleared Jan 30, 1984
WHEELCHAIR MECHANICAL
K840024 · IOR
Amico Lab, Inc.
Physical Medicine · 25d
Cleared Jan 30, 1984
HAYDAY IRRIT-EASER WAND
K840035 · ISA
Hayday Irrit-Easer
Physical Medicine · 25d
Cleared Jan 30, 1984
BILE ESCULIN AGAR PLATE
K840068 · JSH
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Jan 30, 1984
ANAEROBIC AGAR PLATE
K840069 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Jan 30, 1984
EGG YOLK AGAR PLATE
K840070 · JSH
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Jan 30, 1984
BORDET GENGOU AGAR PLATE
K840072 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Jan 30, 1984
SABOURAUD DEXTROSE AGAR TUBE
K840078 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d