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
169585–169608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1979
SERUM PAK, HCG CONTROL
K790129 · JJX
Mallinckrodt Critical Care
Chemistry · 57d
Cleared Mar 21, 1979
SUNLAMP
K790167 · FTC
Kneilsly Group Ent.
General & Plastic Surgery · 64d
Cleared Mar 21, 1979
PORTABLE WHEELCHAIR & CARRYING CASE
K790183 · IOR
Fred Sammons, Inc.
Physical Medicine · 54d
Cleared Mar 21, 1979
NTSH AUTOPAK TEST DELIVERY SYSTEM
K790260 · JLW
Micromedic Systems
Toxicology · 43d
Cleared Mar 21, 1979
DATA-TOPE TRI-RAC RADIOASSAY CONTROL
K790264 · JJY
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 43d
Cleared Mar 21, 1979
SENSI-TEX
K790267 · JHJ
Hoffmann-La Roche, Inc.
Chemistry · 43d
Cleared Mar 21, 1979
MAMMOGRAPHY SYSTEM AND CASSETTE
K790273 · IZH
Agfa-Gevaert, Inc.
Radiology · 41d
Cleared Mar 21, 1979
DIAGNOSTIC SET, LIPO-FRAX
K790281 · LBS
Analytical Products, Inc.
Chemistry · 36d
Cleared Mar 21, 1979
BUFFER, CORNING MOPSO
K790294 · JHX
Corning Medical & Scientific
Chemistry · 41d
Cleared Mar 21, 1979
PRESSURE MONITOR, MODEL 212
K790302 · HRW
Zatek
Neurology · 36d
Cleared Mar 21, 1979
HEMOGLOBIN CONTROLS
K790310 · GGM
Electrophoresis Corp.
Hematology · 36d
Cleared Mar 21, 1979
LDH ISOENZYME REAGENT
K790311 · CFE
Electrophoresis Corp.
Hematology · 36d
Cleared Mar 21, 1979
ORTHO-TOLUIDINE REAGENT SET
K790319 · CGE
Fisher Scientific Co., LLC
Toxicology · 34d
Cleared Mar 21, 1979
COAG-A-MATE 2001
K790323 · JPA
General Diagnostics
Hematology · 34d
Cleared Mar 21, 1979
STIMTECH TENS ELECTRODE
K790345 · GXY
Stimulation Technology, Inc.
Neurology · 28d
Cleared Mar 21, 1979
ACTIVATOR
K790346 · JBP
Tri-Med, Inc.
Hematology · 28d
Cleared Mar 21, 1979
FLUID ADMINISTRATION CAT.#14-923
K790358 · GAZ
Norton Performance Plastics Corp.
General Hospital · 36d
Cleared Mar 21, 1979
HALOTHANE VAPORIZER 950, & ENFLURANE 951
K790359 · CAD
Siemens Corp.
Anesthesiology · 27d
Cleared Mar 21, 1979
MODIFIED THAYER MARTIN AGAR
K790368 · JTY
Biomedia, Inc.
Pathology · 27d
Cleared Mar 21, 1979
LOW-TOX-H RABBIT COMPLEMENT
K790380 · KTQ
Cederlane Labs , Ltd.
Toxicology · 22d
Cleared Mar 21, 1979
ULTRASONIC DIAGNOSTIC SYSTEM
K790396 · IYO
Hoffrel Instruments, Inc.
Radiology · 23d
Cleared Mar 21, 1979
EMIT QUINIDINE ASSAY
K790403 · LAR
Syva Co.
Toxicology · 23d
Cleared Mar 21, 1979
DTT SYSTEM
K790404 · KWQ
Depuy, Inc.
Orthopedic · 23d
Cleared Mar 21, 1979
MODEL 8100 PRE-FILLED INTRAUTERINE
K790418 · KXO
Ge Medical Systems Information...
Radiology · 21d