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

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175,820 results
126409–126432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 1990
TOPOGRAPHIC MODELING SYSTEM
K901363 · HLQ
Computed Anatomy, Inc.
Ophthalmic · 63d
Cleared May 25, 1990
CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430
K901380 · GKP
Helena Laboratories
Hematology · 64d
Cleared May 24, 1990
MODIFIED MINIMED III INFUSION PUMP
K895436 · FRN
Medtronic Minimed
General Hospital · 289d
Cleared May 24, 1990
DSL C-PEPTIDE RIA (DSL #7000)
K896420 · JKD
Diagnostic Systems Laboratories, Inc.
Chemistry · 197d
Cleared May 24, 1990
IM COLLAGEN SHIELD
K896449 · MOE
Intermedical, Inc.
Ophthalmic · 196d
Cleared May 24, 1990
ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.
K896713 · KOE
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology · 176d
Cleared May 24, 1990
IRRIGATION TRAY
K896800 · KYZ
Westmark, Sterile Packing Systems,...
General Hospital · 174d
Cleared May 24, 1990
NIIC MODEL: DX901 ASPIRATION SYSTEM
K900185 · JFL
Niic U.S.A., Inc.
Chemistry · 128d
Cleared May 24, 1990
DISTRAC(TM) TABLE
K900475 · ITH
Lossing Orthopedic, Inc.
Physical Medicine · 112d
Cleared May 24, 1990
POLY-OP (TM)
K900759 · OCF
Nu-Gyn-Tek, Inc.
Neurology · 97d
Cleared May 24, 1990
SYLVAN PEDIASCAN 200 TRANSILLUMINATOR
K901309 · HJN
Sylvan Corp.
Ophthalmic · 65d
Cleared May 24, 1990
SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE
K901438 · GAA
Telemed Systems, Inc.
General & Plastic Surgery · 59d
Cleared May 24, 1990
QUICK CHEM II
K901695 · JJQ
Seradyn, Inc.
Chemistry · 44d
Cleared May 24, 1990
KLEIN MICRO-CANNULA(TM)
K901717 · GEA
Jeff Klein Surgical, Inc.
General & Plastic Surgery · 41d
Cleared May 24, 1990
KLEIN LAMPREY-CANNULA(TM)
K901718 · GEA
Jeff Klein Surgical, Inc.
General & Plastic Surgery · 41d
Cleared May 24, 1990
M.D.C. PORTA-LIFT
K901793 · ING
Metal Dynamics Corp.
Physical Medicine · 35d
Cleared May 24, 1990
CHICK III SURGICAL LIGHTING SYSTEM
K901830 · FSY
Chick Medical Products
General & Plastic Surgery · 30d
Cleared May 24, 1990
GRAVITY DOWN WHEELCHAIR LIFT
K901989 · ING
Crow River Industries, Inc.
Physical Medicine · 22d
Cleared May 23, 1990
ACUSON L538 TRANSDUCER
K893863 · ITX
Acuson Computed Sonography
Radiology · 364d
Cleared May 23, 1990
FLEXMEDICS GUIDEWIRE .012 ONLY
K895899 · DQX
Flexmedics
Cardiovascular · 229d
Cleared May 23, 1990
WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE
K897033 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 156d
Cleared May 23, 1990
MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID
K897035 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 156d
Cleared May 23, 1990
PHONAK ITE 8000, 7000, 6000 ITE HEARING AID
K900675 · ESD
Phonak, Inc.
Ear, Nose, Throat · 100d
Cleared May 23, 1990
PANORAMIC MODEL X-CALIBER X-RAY
K900681 · EAP
Belmont Equipment Corp.
Radiology · 100d