FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79897–79920 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2001
SPIFE IFE CALIBRATOR AND CONTROL KIT
K010617 · DEW
Helena Laboratories
Immunology · 14d
Cleared Mar 15, 2001
NEMIO
K010631 · IYN
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Mar 15, 2001
GALIX GBI -3S-LP
K992706 · MLO
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 581d
Cleared Mar 14, 2001
'ALL 2000' % OXYGEN ANALYZER
K002382 · CCL
Analytical Industries, Inc.
Anesthesiology · 222d
Cleared Mar 14, 2001
O2/CO2 NASAL FILTERLINE
K010024 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 70d
Cleared Mar 14, 2001
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
K010061 · CEM
Dade Behring, Inc.
Chemistry · 65d
Cleared Mar 14, 2001
Y2000 POCKET RESCUE
K010191 · CBP
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 51d
Cleared Mar 14, 2001
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
K010352 · JEY
Inion , Ltd.
Dental · 36d
Cleared Mar 14, 2001
INNOVO
K010359 · FMF
Novo Nordisk A/S
General Hospital · 36d
Cleared Mar 14, 2001
SMOOTH-FLO CIRCUIT
K010402 · BTT
Hudson Respiratory Care, Inc.
Anesthesiology · 30d
Cleared Mar 14, 2001
BIOSORBFX AND BIOSORBPDX MESH
K010687 · JEY
Bionx Implants, Inc.
Dental · 6d
Cleared Mar 13, 2001
MEMOGRAPH
K001353 · HBW
Biomedical Ent., Inc.
Neurology · 319d
Cleared Mar 13, 2001
MEMOGRAPH
K001354 · JDR
Biomedical Ent., Inc.
Orthopedic · 319d
Cleared Mar 13, 2001
ULTRASONIC NEBULIZER, MODEL NE-520
K002153 · CAF
Medisana USA, Inc.
Anesthesiology · 239d
Cleared Mar 13, 2001
PRONEB ULTRA MODEL NUMBER 85B0100
K002862 · BTI
Pari Holding Co.
Anesthesiology · 181d
Cleared Mar 13, 2001
GRAMSORB SYNTHETIC ABSORBABLE SUTURE
K003017 · GAM
Gramsmed, LLC
General & Plastic Surgery · 167d
Cleared Mar 13, 2001
ASPIRE COVERED STENT AND DELIVERY CATHETER
K003173 · ESW
Vascular Architects, Inc.
Gastroenterology & Urology · 154d
Cleared Mar 13, 2001
N LATEX CYSTATIN C
K003503 · NDY
Dade Behring, Inc.
Chemistry · 120d
Cleared Mar 13, 2001
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
K003614 · GEX
Coherent Star
General & Plastic Surgery · 111d
Cleared Mar 13, 2001
3D-DOCTOR
K003746 · LLZ
Able Software Corp.
Radiology · 99d
Cleared Mar 13, 2001
TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)
K003911 · KWP
Terray Corp.
Orthopedic · 84d
Cleared Mar 13, 2001
FUNCTIONAL BRAIN MAPPING OPTION FOR MRI
K003947 · LNH
GE Medical Systems
Radiology · 82d
Cleared Mar 13, 2001
BEAM BLOCK TRAYS
K004015 · IYE
Arplay Medical S.A.
Radiology · 76d
Cleared Mar 13, 2001
STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM
K010062 · IYE
Arplay Medical S.A.
Radiology · 64d