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
124033–124056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1990
CURITY PEDIATRIC CONTINUOUS CAUDAL ANESTHESIA TRAY
K902647 · CAZ
Kendall Healthcare Products Co....
Anesthesiology · 167d
Cleared Nov 29, 1990
ADVANCE LAPAROTOMY SPONGE, LAP SPONGE
K903358 · GDY
Advance Medical Designs, Inc.
General & Plastic Surgery · 126d
Cleared Nov 29, 1990
CATHETERIZATION C-ARM SUPPORT MH-51B(F)
K903371 · IZI
Shimadzu Medical Systems
Radiology · 126d
Cleared Nov 29, 1990
CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A
K903372 · IZI
Shimadzu Medical Systems
Radiology · 126d
Cleared Nov 29, 1990
CATHETERIZATION C-ARM SUPPORT MH-51C(F)
K903373 · IZI
Shimadzu Medical Systems
Radiology · 126d
Cleared Nov 29, 1990
HEMOCHRON(R) HEPARIN RESPONSE TEST
K904003 · KFF
Intensive Technology, Inc.
Hematology · 92d
Cleared Nov 29, 1990
HUESTIS FLEXI-BOARD
K904005 · JAD
Huestis Machine Corp.
Radiology · 92d
Cleared Nov 29, 1990
PHILIPS INTEGRIS I 2000 SYSTEM
K904012 · JAA
Philips Medical Systems, Inc.
Radiology · 92d
Cleared Nov 29, 1990
KXO-80C/80D
K904043 · IZO
Toshiba America Medical Systems, In.C
Radiology · 86d
Cleared Nov 29, 1990
TF-63SA
K904044 · KPW
Toshiba America Medical Systems, In.C
Radiology · 86d
Cleared Nov 29, 1990
ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY
K904158 · FCM
Welcon, Inc.
Gastroenterology & Urology · 83d
Cleared Nov 29, 1990
ECONOMY C-ARM TABLE, MODEL # 056-005
K904187 · IXQ
Atomic Products Corp.
Radiology · 78d
Cleared Nov 29, 1990
FLOCARE
K904193 · BYD
Flocare Medical
Anesthesiology · 78d
Cleared Nov 29, 1990
STAT.BR TM
K904482 · ELW
Kerr Corporation (Danbury)
Dental · 58d
Cleared Nov 29, 1990
JAIN GRAFT ASSIST
K904536 · GCZ
Jain Surgical Equipment, Inc.
General & Plastic Surgery · 56d
Cleared Nov 29, 1990
IVT RAST TRACER
K904661 · DHB
In Vitro Technologies, Inc.
Immunology · 48d
Cleared Nov 29, 1990
ELEGANCE FERRITIN ELISA
K904822 · DBF
Bioclone Australia Pty , Ltd.
Immunology · 36d
Cleared Nov 29, 1990
FLEXI-TRAK(TM) ANCHORING DEVICE
K905128 · KNY
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 15d
Cleared Nov 29, 1990
RUBBER LATEX SURGICAL GLOVES, STERILE
K905161 · KGO
Rfb Latex Pvt. , Ltd.
General Hospital · 13d
Cleared Nov 28, 1990
NORPLANT(R) TROCAR
K903490 · FMI
Wyeth-Ayerst Laboratories, Inc.
General Hospital · 127d
Cleared Nov 28, 1990
HYCOR ACCUPINCH METHAMPHETAMINE TEST
K904115 · DKZ
Hycor Biomedical, Inc.
Toxicology · 83d
Cleared Nov 28, 1990
BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT
K904184 · LBR
Biotron U.S.A., Inc.
Chemistry · 77d
Cleared Nov 28, 1990
STRATUS PRIMIDONE FLUOROMETRIC ENZYME
K904683 · LFT
Baxter Healthcare Corp
Chemistry · 44d
Cleared Nov 28, 1990
SECONDARY CALIBRATORS
K904698 · JIT
Bionostics, Inc.
Chemistry · 43d