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
104353–104376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1995
B-D DURASAFE)TM) VARIABLE EXTENSION COMBINED SPINAL EPIDURAL *CSE) NEEDLE...
K945497 · CAZ
Bd Becton Dickinson Vacutainer...
Anesthesiology · 97d
Cleared Feb 13, 1995
OCUSYSTEM(ART)
K945583 · HQC
Arent Fox
Ophthalmic · 91d
Cleared Feb 13, 1995
PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS...
K945617 · FPA
Pharma-Plast Intl. A/S
General Hospital · 90d
Cleared Feb 13, 1995
KARL STORZ KNIVES, CURETTES
K945686 · EZO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 84d
Cleared Feb 13, 1995
PROPHY PRO.
K945834 · EGS
Hyman, Phelps & McNamara, P.C.
Dental · 76d
Cleared Feb 13, 1995
ARGIDENE(TM) GEL
K945835 · MGQ
Telios Pharmaceuticals, Inc.
General & Plastic Surgery · 76d
Cleared Feb 13, 1995
GORE-TEX(R) CURVED SURGICALMEMBRANE
K945899 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 73d
Cleared Feb 13, 1995
CONMED 7/8MM GASKET REDUCER FOR USE WITH TROGARD(TM) TROCAR SLEEVE
K946235 · HET
Conmedcorp
Obstetrics & Gynecology · 53d
Cleared Feb 13, 1995
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER
K946243 · EXJ
Coloplast A/S
Gastroenterology & Urology · 53d
Cleared Feb 13, 1995
FLEX BLUE
K950318 · CBH
King Systems Corp.
Anesthesiology · 18d
Cleared Feb 13, 1995
KARL STORZ ADAPTERS FOR DOCUMENTATION PURPOSES
K950336 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 17d
Cleared Feb 10, 1995
SNOREMASTER SNORE REMEDY
K932932 · LQZ
The Snoremaster Co.
Dental · 604d
Cleared Feb 10, 1995
TINA-QUANT MICROALBUMIN
K932950 · JIR
Boehringer Mannheim Corp.
Chemistry · 603d
Cleared Feb 10, 1995
REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING
K935184 · DSP
St. Jude Medical, Inc.
Cardiovascular · 472d
Cleared Feb 10, 1995
CLENSICAIR LOW AIRLOSS HYDROTHERAPY
K941610 · IOQ
Support Systems Intl.
Physical Medicine · 316d
Cleared Feb 10, 1995
ORTHOVITA BIOGRAN
K941780 · LYC
Orthovita Co.
Dental · 301d
Cleared Feb 10, 1995
ZOLL POWERBASE(TM)
K942850 · MKJ
Zoll Medical Corp
Cardiovascular · 239d
Cleared Feb 10, 1995
MONARCH AP(TM)
K943597 · MAV
Merit Medical Systems, Inc.
Cardiovascular · 202d
Cleared Feb 10, 1995
QUICK CHECKER HCG PREGNANCY TEST
K943859 · JHI
Mizuho USA, Inc.
Chemistry · 186d
Cleared Feb 10, 1995
NU-SITE
K943897 · FPA
Medex, Inc.
General Hospital · 184d
Cleared Feb 10, 1995
BAXTER HANDLE MODEL 1150
K944214 · DTJ
Baxter Edwards
Cardiovascular · 165d
Cleared Feb 10, 1995
ACE IRON REAGENT
K944911 · JIY
Schiapparelli Biosystems, Inc.
Chemistry · 128d
Cleared Feb 10, 1995
ALKO CAL PACKS FOR CORNING 654 ANALYZERS
K944922 · JIX
Alko Diagnostic Corp.
Chemistry · 127d
Cleared Feb 10, 1995
QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB...
K945080 · GTY
Quidel Corp.
Microbiology · 116d