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

Filters: Cleared only ×
174,955 results
103849–103872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1995
B. BRAUN IV START KITS
K950184 · LRS
B. Braun of America, Inc.
General & Plastic Surgery · 57d
Cleared Mar 15, 1995
KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES
K950433 · FGA
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 41d
Cleared Mar 15, 1995
SAFEDWEEL DRESSING CHANGE TRAY
K950438 · FRG
Becton Dickinson Vascular Access, Inc.
General Hospital · 41d
Cleared Mar 15, 1995
HAPEX MALLEABLE PORP
K950885 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
HAPEX PORP
K950886 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
HAPEX INCUS
K950887 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
BIPOLAP HOOK ELECTRODE
K950932 · GEI
Berchtold Holding GmbH
General & Plastic Surgery · 14d
Cleared Mar 15, 1995
HAPES MALLEABLE INCUS STAPES
K950984 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 12d
Cleared Mar 15, 1995
RITE-BITE BIOPSY FORCEPS
K951048 · FCL
Mill-Rose Laboratory
Gastroenterology & Urology · 9d
Cleared Mar 14, 1995
AGRAM SPYRAL ELECTRODE
K934779 · GXZ
Agram Export-Import Co.
Neurology · 524d
Cleared Mar 14, 1995
TYMPANOSTOMY (VENTILATION) TUBE
K941407 · ETD
Xomed-Treace, Inc.
Ear, Nose, Throat · 356d
Cleared Mar 14, 1995
LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIES
K943716 · GEX
Heraeus Surgical, Inc.
General & Plastic Surgery · 225d
Cleared Mar 14, 1995
DISPOSABLE LASER SWEEP TIP
K944437 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 183d
Cleared Mar 14, 1995
GENERAL ELECTRIC AMX 110, AMX II AND AMX 3
K944442 · IZL
Pro-Tronics, Inc.
Radiology · 183d
Cleared Mar 14, 1995
IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE
K944994 · HQC
Chiron Vision Corp.
Ophthalmic · 153d
Cleared Mar 14, 1995
VACPLUS
K945062 · JCX
Kinetic Concepts, Inc.
General & Plastic Surgery · 151d
Cleared Mar 14, 1995
PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION
K945460 · JAA
Philips Medical Systems North...
Radiology · 127d
Cleared Mar 14, 1995
HRSW OPTION FOR CT TWIN FLASH
K945512 · JAK
Elscint, Inc.
Radiology · 125d
Cleared Mar 14, 1995
STRYKER AGILITY INTENSIVE CARE BED
K946149 · FNL
Stryker Medical
General Hospital · 88d
Cleared Mar 14, 1995
INFINITECH SOFT TIP FLUTE NEEDLE
K946181 · HQE
Surgical Technologies, Inc.
Ophthalmic · 84d
Cleared Mar 14, 1995
VOLKER NURSING BED MODEL 2080E & 2090E
K946208 · FNL
Volker Healthcare, Inc.
General Hospital · 83d
Cleared Mar 14, 1995
STEREOPLAN
K946252 · HAW
Radionics Software Applications, Inc.
Neurology · 81d
Cleared Mar 14, 1995
DESERET(R) I.V. LOOP AND DESERET (R) J LOOP
K950303 · FPA
Becton Dickinson Vascular Access, Inc.
General Hospital · 48d
Cleared Mar 14, 1995
DESERET (R) T-PORT (R) MULTI FLO(TM) AND DESERET (R)PRN ADAPTER
K950304 · FPA
Becton Dickinson Vascular Access, Inc.
General Hospital · 48d