FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
116521–116544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1992
INTERLINK(TM) INJECTION SITE
K922558 · FPA
Baxter Healthcare Corp
General Hospital · 144d
Cleared Oct 19, 1992
ADEPT ENDOSCOPIC POSITIONER
K922625 · GAD
Andronic Devices, Ltd.
General & Plastic Surgery · 138d
Cleared Oct 19, 1992
ADEPT INSTRUMENT POSITIONING ACCESSORY
K922626 · GAD
Andronic Devices, Ltd.
General & Plastic Surgery · 138d
Cleared Oct 19, 1992
MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES
K923407 · LDF
Medtronic Vascular
Cardiovascular · 101d
Cleared Oct 19, 1992
OPHTHALMIC TRICHIASIS PROBE
K923629 · HPS
Mira, Inc.
Ophthalmic · 90d
Cleared Oct 19, 1992
DISPOSABLE ENDOILLUMINATOR
K923774 · EQH
O.R. Specialties, Inc.
Ear, Nose, Throat · 83d
Cleared Oct 19, 1992
MERITEC C. DIFFICILE CONTROLS
K924062 · MCB
Meridian Diagnostics, Inc.
Microbiology · 68d
Cleared Oct 19, 1992
PREMIER C. DIFFICILE TOXIN A CONTROLS
K924136 · LLH
Meridian Diagnostics, Inc.
Chemistry · 62d
Cleared Oct 19, 1992
OLYMPUS AMYLASE REAGENT
K924339 · CIW
Olympus Corp.
Chemistry · 52d
Cleared Oct 19, 1992
OLYMPUS CALCIUM REAGENT
K924435 · CIC
Olympus Corp.
Chemistry · 48d
Cleared Oct 19, 1992
OLYMPUS MAGNESIUM REAGENT
K924658 · JGJ
Olympus Corp.
Chemistry · 34d
Cleared Oct 19, 1992
OLYMPUS CREATININE REAGENT
K924692 · CGX
Olympus Corp.
Chemistry · 32d
Cleared Oct 16, 1992
ISOL-AIDE
K915287 · CBN
Computronic Systems
Anesthesiology · 330d
Cleared Oct 16, 1992
MINUTEX D-DIMER LATEX TEST
K920668 · GHH
Biopool AB
Hematology · 246d
Cleared Oct 16, 1992
ROADRUNNER RLTF GUIDE WIRE
K920824 · DQX
Cook, Inc.
Cardiovascular · 235d
Cleared Oct 16, 1992
A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM
K921475 · LJT
Therex Corp.
General Hospital · 200d
Cleared Oct 16, 1992
SCIMED SIDEWINDER TUOHY-BORST Y-ADAPTER
K921577 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 197d
Cleared Oct 16, 1992
PATIENT INFORMATION MANAGER (PIM)
K921986 · IZH
Continental X-Ray Corp.
Radiology · 171d
Cleared Oct 16, 1992
E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS
K922287 · KPQ
I.Z.I. Corp.
Radiology · 154d
Cleared Oct 16, 1992
ENCORE SS-B
K922340 · LLL
Clark Laboratories, Inc.
Immunology · 150d
Cleared Oct 16, 1992
IRRIVAGE
K922785 · EYF
Autovage
General & Plastic Surgery · 129d
Cleared Oct 16, 1992
GAMMA 600T
K923736 · KPS
Strichman Medical Equipment, Inc.
Radiology · 81d
Cleared Oct 16, 1992
PULSE IM RED CELL TEST
K923767 · KTN
Pulse Scientific, Inc.
Immunology · 80d
Cleared Oct 16, 1992
PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTION
K923813 · IZI
Philips Medical Systems, Inc.
Radiology · 79d