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
129049–129072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1989
SYSTEMATE(TM) IRON ITEM NUMBER: 65417
K895249 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Oct 31, 1989
SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402
K895250 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Oct 31, 1989
ULTRACISION ULTRASONIC SCALPEL
K895252 · GEI
Ultracision, Inc.
General & Plastic Surgery · 71d
Cleared Oct 31, 1989
HVA EIA KIT YAMASA
K895288 · CDF
Yamasa Shoy Co., Ltd.
Chemistry · 67d
Cleared Oct 31, 1989
LID LOC
K895364 · HOY
Spectrum Co.
Ophthalmic · 64d
Cleared Oct 31, 1989
CYBERFLUOR FIAGEN TSH
K895396 · JLW
Cyberfluor, Inc.
Toxicology · 60d
Cleared Oct 31, 1989
BIOPSY FORCEPS
K895415 · EOQ
Symbiosis Corp.
Ear, Nose, Throat · 56d
Cleared Oct 31, 1989
S.M.P.U. LATEX EXAMINATION GLOVES
K895438 · LYY
P.T. Surya Milani Plastic Utama
General Hospital · 56d
Cleared Oct 31, 1989
CANON AUTO REF-KERATOMETER RK-2
K895475 · HLQ
Canon USA, Inc.
Ophthalmic · 50d
Cleared Oct 31, 1989
BIO-RAD MODULAR AIR COMPRESSOR
K895575 · HKX
Bio-Rad
Ophthalmic · 47d
Cleared Oct 31, 1989
TUBING ORGANIZER
K895706 · KNT
3t Products, Inc.
Gastroenterology & Urology · 36d
Cleared Oct 31, 1989
IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)
K895723 · JFH
Diagnostic Products Corp.
Chemistry · 36d
Cleared Oct 31, 1989
LEECO PREVIEW(R) EBV (EIA)
K895765 · KTN
Leeco Diagnostics, Inc.
Immunology · 35d
Cleared Oct 31, 1989
INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET
K895827 · LGR
Innotron of Oregon, Inc.
Toxicology · 29d
Cleared Oct 31, 1989
HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE
K895868 · GYK
Baxter Healthcare Corp
Neurology · 27d
Cleared Oct 31, 1989
DETECTADOT SYSTEM 2000 HETEROPHILE TEST
K895891 · KTN
Gull Laboratories, Inc.
Immunology · 26d
Cleared Oct 31, 1989
MODEL FEL5100 FLOOR LIGHT
K895950 · FSS
F.W. Lang Co.
General & Plastic Surgery · 21d
Cleared Oct 30, 1989
E-RAM
K884126 · DSH
Reynolds Medical , Ltd.
Cardiovascular · 395d
Cleared Oct 30, 1989
1100 VITAL SIGNS MONITOR
K884643 · DSI
Criticare Systems, Inc.
Cardiovascular · 357d
Cleared Oct 30, 1989
SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES
K892323 · DSB
Seismed Instruments, Inc.
Cardiovascular · 207d
Cleared Oct 30, 1989
TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR)
K893609 · BTR
Leonides Y. Teves, M.D., P.A.
Anesthesiology · 173d
Cleared Oct 30, 1989
IMMUNODOT LYME TEST
K894410 · LSR
General Biometrics, Inc.
Microbiology · 105d
Cleared Oct 30, 1989
CIBA CORNING CERTAIN LYTE
K894576 · JJR
Ciba Corning Diagnostics Corp.
Chemistry · 101d
Cleared Oct 30, 1989
DART UREA NITROGEN
K894836 · CDQ
Coulter Electronics, Inc.
Chemistry · 91d