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
76489–76512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 2002
TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
K013775 · HRS
Stryker Leibinger
Orthopedic · 56d
Cleared Jan 08, 2002
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
K013956 · MSV
Diamedix Corp.
Immunology · 39d
Cleared Jan 08, 2002
BOEHRINGER MRI SUCTION REGULATORY
K013976 · KDP
Boehringer Laboratories
General Hospital · 36d
Cleared Jan 08, 2002
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM
K014078 · CAW
On Site Gas Systems, Inc.
Anesthesiology · 28d
Cleared Jan 08, 2002
APEX ADULT HOLLOWE FIBER OXYGENATOR
K014080 · DTZ
Dideco S.P.A.
Cardiovascular · 28d
Cleared Jan 08, 2002
HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
K014083 · CAC
Haemonetics Corp.
Anesthesiology · 28d
Cleared Jan 08, 2002
OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
K014100 · GEX
Opusdent , Ltd.
General & Plastic Surgery · 26d
Cleared Jan 08, 2002
NLITE SYSTEM
K014130 · GEX
Icn Photonics , Ltd.
General & Plastic Surgery · 22d
Cleared Jan 07, 2002
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS,...
K011537 · KDI
Dynamic Technology Corp.
Gastroenterology & Urology · 234d
Cleared Jan 07, 2002
PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP
K012275 · HGX
Limerick, Inc.
Obstetrics & Gynecology · 172d
Cleared Jan 07, 2002
INCARE INTERMITTENT CATHETER
K013345 · KOD
Hollister, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 07, 2002
SHARGHP A.V. FISTULA NEEDLE SET
K013384 · FIE
Shargh Pharmaceutical Co., Inc.
Gastroenterology & Urology · 87d
Cleared Jan 07, 2002
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
K013523 · LHI
Shire Biologics, Inc.
General Hospital · 76d
Cleared Jan 07, 2002
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
K014007 · FGE
Guidant Corp.
Gastroenterology & Urology · 33d
Cleared Jan 07, 2002
NYCOCARD CRP CONTROL
K014084 · DCK
Primus Corp.
Immunology · 27d
Cleared Jan 07, 2002
M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
K014191 · IYN
Philips Medical Systems
Radiology · 17d
Cleared Jan 04, 2002
PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE...
K013174 · EZL
Porges S.A.
Gastroenterology & Urology · 102d
Cleared Jan 04, 2002
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
K014037 · KRH
St. Jude Medical, Inc.
Cardiovascular · 28d
Cleared Jan 03, 2002
NEOLEAD
K011564 · DRX
Neotech Products, Inc.
Cardiovascular · 227d
Cleared Jan 03, 2002
3420 DIGIT PULSE OXIMETER, MODEL 3420
K013171 · DQA
Bci, Inc.
Anesthesiology · 101d
Cleared Jan 03, 2002
MODIFICATION TO: POCKETVIEW ECG SOFTWARE
K013311 · MHX
Micromedical Industries, Ltd.
Cardiovascular · 91d
Cleared Jan 03, 2002
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
K013319 · DQA
Nonin Medical, Inc.
Anesthesiology · 90d
Cleared Jan 03, 2002
YELLOW SPECIAL
K013506 · EJT
Metalor Technologies USA
Dental · 73d
Cleared Jan 03, 2002
NUMED MULLINS PTA CATHETER
K013601 · DQY
NuMED, Inc.
Cardiovascular · 64d