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

Filters: Cleared only ×
175,820 results
105337–105360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1995
DEXIDE INSUFFLATION TUBING WITH FILTER
K944509 · HIF
Dexide, Inc.
Obstetrics & Gynecology · 145d
Cleared Feb 07, 1995
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
K944664 · JIQ
Wako Chemicals USA, Inc.
Chemistry · 138d
Cleared Feb 07, 1995
VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID})
K944671 · EOB
Jedmed Instrument Co.
Ear, Nose, Throat · 138d
Cleared Feb 07, 1995
GABRIEL URETERAL ILLUMINATOR SYSTEM II
K945088 · FCS
Gabriel Medical, Inc.
Gastroenterology & Urology · 113d
Cleared Feb 07, 1995
KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP
K945210 · LJH
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 105d
Cleared Feb 07, 1995
IVR MASTER
K945389 · LLZ
Shimadzu Corp.
Radiology · 96d
Cleared Feb 07, 1995
WESTMED PEDIATRIC AND ADULT AEROSOL MASK
K945472 · BYG
Westmed Intl.
Anesthesiology · 91d
Cleared Feb 07, 1995
CATO FIRST PICC KIT
K945499 · LJS
Catco Medical, Inc.
General Hospital · 90d
Cleared Feb 07, 1995
QC CAP
K945567 · KDJ
Medionics International, Inc.
Gastroenterology & Urology · 133d
Cleared Feb 07, 1995
PREPPIES SKIN BARRIER WIPE
K945675 · FRO
Kendall Healthcare Products Co....
General & Plastic Surgery · 81d
Cleared Feb 07, 1995
METZLER, ALPINA, MENRAD, POLICE, L. BIAGIOTTI, CFF, R. LAUREN, POLO,...
K945680 · HQY
Solex Marketing, Inc.
Ophthalmic · 78d
Cleared Feb 07, 1995
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE
K945762 · HQP
Aaron Medical Industries
Ophthalmic · 90d
Cleared Feb 07, 1995
LOW TEMPERATURE CAUTERY ELONGATED FINE TIP
K945763 · HQP
Aaron Medical Industries
Ophthalmic · 90d
Cleared Feb 07, 1995
DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER
K945789 · HIF
Deroyal Industries, Inc.
Obstetrics & Gynecology · 74d
Cleared Feb 07, 1995
BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP
K945813 · FCG
Bd Becton Dickinson Vacutainer...
Gastroenterology & Urology · 71d
Cleared Feb 07, 1995
ROSE K LENS
K945955 · HQD
Rose K International , Ltd.
Ophthalmic · 63d
Cleared Feb 07, 1995
LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENS
K945981 · LPL
Permeable Technologies, Inc.
Ophthalmic · 61d
Cleared Feb 07, 1995
CHIN IMPLANT STYLE I
K945998 · FWP
King & Spalding
General & Plastic Surgery · 69d
Cleared Feb 07, 1995
EMERGENCY/ACCIDENT TROLLEY 550
K946101 · FPO
Hogan & Hartson
General Hospital · 55d
Cleared Feb 07, 1995
ROCHE-TDM ONLEIN(TM) CONTROLS
K946119 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 54d
Cleared Feb 07, 1995
COLLAGEN INTRACANALICULAR PLUG
K946357 · LZU
Oasis Medical, Inc.
Ophthalmic · 39d
Cleared Feb 07, 1995
SUNGLASSES
K950079 · HQY
Gianni Versace
Ophthalmic · 28d
Cleared Feb 07, 1995
PEDIA PALS, INCORPORATED
K950086 · EPY
Pedia Pals, Inc.
General & Plastic Surgery · 28d
Cleared Feb 07, 1995
KARL STORZ BOUGIES AND DILATORS
K950125 · FAX
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 26d