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
163249–163272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1981
LKB-BROMMA 2188 ULTROTOME NOVA
K812158 · IDM
Lkb Instruments, Inc.
Hematology · 49d
Cleared Sep 16, 1981
FLUORO AUTOMATIC BRIGHTNESS SYS
K812217 · JAA
Keystone X-Ray, Inc.
Radiology · 42d
Cleared Sep 16, 1981
PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL
K812270 · DTB
Diag Corp.
Cardiovascular · 34d
Cleared Sep 16, 1981
CRYOSAN NORMAL SALINE
K812309 · GIF
Cryosan, Inc.
Chemistry · 30d
Cleared Sep 16, 1981
CIRCULATING CYTO-THERMS
K812311 · KZL
Cryosan, Inc.
Hematology · 30d
Cleared Sep 16, 1981
KERMATH L/C ARM
K812332 · KPR
Kermath Mfg. Corp.
Radiology · 29d
Cleared Sep 16, 1981
KF-E SERIES OF HOLLOW FIBER DIALYZERS
K812353 · FJI
Medisystems Corp.
Gastroenterology & Urology · 28d
Cleared Sep 16, 1981
MEDTRONIC #3798 ELECTRODE
K812418 · GXY
Medtronic Vascular
Neurology · 23d
Cleared Sep 16, 1981
3M INFUSION SYSTEM
K812442 · FRN
3M Company
General Hospital · 20d
Cleared Sep 16, 1981
INFUSION PUMP
K812499 · FRN
Nu Tech Medical Systems
General Hospital · 16d
Cleared Sep 16, 1981
PALL ULTIPOR VACUUM LINE BACTERIA FITLER
K812505 · JQC
Pall Biomedical Products Co.
Chemistry · 15d
Cleared Sep 16, 1981
TRAVENOL INFUSION CONTROLLER 2M8052
K812510 · LDR
Travenol Laboratories, S.A.
General Hospital · 14d
Cleared Sep 16, 1981
MICRO BLADE II
K812526 · GES
Vxtra Corp.
General & Plastic Surgery · 14d
Cleared Sep 16, 1981
IVA SEAL II
K812527 · KPE
U.S. Clinical Products, Inc.
General Hospital · 14d
Cleared Sep 14, 1981
NON-MEASURING EXERCISERS
K812351 · ION
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Sep 14, 1981
HYGIENE ADAPTORS
K812352 · ILS
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Sep 14, 1981
CHAIR, ADJUSTABLE, MECHANICAL
K812399 · INN
Kaye Products, Inc.
Physical Medicine · 25d
Cleared Sep 14, 1981
CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O
K812401 · IPT
Surgical Appliance Industries, Inc.
Physical Medicine · 25d
Cleared Sep 14, 1981
KALLESTAD 125I ANTISERUM TO HUMAN IGE
K812414 · DHB
Kallestad Laboratories, Inc.
Chemistry · 24d
Cleared Sep 14, 1981
CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS
K812422 · IPY
Surgical Appliance Industries, Inc.
Physical Medicine · 21d
Cleared Sep 14, 1981
NEOPRENE KNEE SUPPORT
K812423 · ITQ
Surgical Appliance Industries, Inc.
Physical Medicine · 21d
Cleared Sep 14, 1981
PHOS MICROTUBES
K812465 · JSF
Carr Microbiologicals
Microbiology · 14d
Cleared Sep 14, 1981
ONPX-INDOL MEDIUM MICROTUBES
K812466 · JSE
Carr Microbiologicals
Microbiology · 14d
Cleared Sep 14, 1981
PGUA-INDOL MICROTUBE
K812467 · JSE
Carr Microbiologicals
Microbiology · 14d