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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

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174,955 results
99241–99264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1996
VARELISA PR3-ANCA
K953586 · MOB
Elias U.S.A., Inc.
Immunology · 178d
Cleared Jan 26, 1996
VARELISA MPO-ANCA
K953587 · MOB
Elias U.S.A., Inc.
Immunology · 178d
Cleared Jan 26, 1996
ACCUSCAN MODEL C CO2 LASER SCANNER
K953670 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 172d
Cleared Jan 26, 1996
ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET
K953746 · FPA
Arrow Intl., Inc.
General Hospital · 169d
Cleared Jan 26, 1996
GLOBAL HEALTHCARE FACE MASK
K953754 · FXX
Global Healthcare, Inc.
General Hospital · 168d
Cleared Jan 26, 1996
PRIMALOC CEMENTLESS HIP SYSTEM
K953977 · KWY
Ortho Development Corp.
Orthopedic · 156d
Cleared Jan 26, 1996
ARISTA VINYL EXAMINATION GLOVES
K954153 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 143d
Cleared Jan 26, 1996
SLED UNICOMPARTMENT KNEE SYSTEM
K954186 · HSX
Link America, Inc.
Orthopedic · 142d
Cleared Jan 26, 1996
CONTOUR FLEX VALVES (REGULAR & SMALL)
K954285 · JXG
Radionics, Inc.
Neurology · 134d
Cleared Jan 26, 1996
VERSA-FX FEMORAL FIXATION SYSTEM
K954555 · KTT
Zimmer, Inc.
Orthopedic · 116d
Cleared Jan 26, 1996
DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT
K954684 · JWH
Depuy, Inc.
Orthopedic · 107d
Cleared Jan 26, 1996
DENTAL DAM
K954990 · EIE
The Hygenic Corp.
Dental · 87d
Cleared Jan 26, 1996
REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE
K955000 · LMD
Cerner Corp.
Radiology · 86d
Cleared Jan 26, 1996
APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM
K955007 · GEX
Applied Optronics Corp.
General & Plastic Surgery · 86d
Cleared Jan 26, 1996
APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE
K955014 · GEX
Applied Optronics Corp.
General & Plastic Surgery · 86d
Cleared Jan 26, 1996
HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR
K955120 · GCM
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 78d
Cleared Jan 26, 1996
SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH
K955253 · JAK
Shimadzu Medical Systems
Radiology · 74d
Cleared Jan 26, 1996
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC
K955254 · JAK
Shimadzu Medical Systems
Radiology · 74d
Cleared Jan 26, 1996
PROTEC COTTON PADDING BANDAGE
K955320 · LGF
Derivadas Degasa S.A. DE C.V.
Orthopedic · 67d
Cleared Jan 26, 1996
DURALASTIC SILICONE TUBING
K955433 · KGZ
Allied Biomedical Corp.
General & Plastic Surgery · 59d
Cleared Jan 26, 1996
PRIME FEMORAL CEMENT PLUG
K955751 · LZN
Orthopaedic Innovations, Inc.
Orthopedic · 37d
Cleared Jan 26, 1996
MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER
K955861 · GEX
Microquartz Medical, Inc.
General & Plastic Surgery · 30d
Cleared Jan 25, 1996
OMEGA CARES SYSTEM
K945068 · DQK
J-F Medical Systems Intl., Inc.
Cardiovascular · 468d
Cleared Jan 25, 1996
ARTHREX BIOABSORBABLE INTERFERENCE SCREW
K945303 · HWC
Arthrex, Inc.
Orthopedic · 454d