FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
70297–70320 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2003
MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K033252 · HWC
Stryker Endoscopy
Orthopedic · 36d
Cleared Nov 13, 2003
MONOJECT INSULIN SYRINGE
K033373 · FMI
Tyco Healthcare
General Hospital · 22d
Cleared Nov 13, 2003
APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82
K033446 · EJT
We Dong Myung Dental Industrial Co.,...
Dental · 15d
Cleared Nov 12, 2003
OXYCON MOBILE
K023120 · BZC
Erich Jaeger GmbH
Anesthesiology · 419d
Cleared Nov 12, 2003
DOC'S BEST WHITE COPPER CEMENT
K031494 · EMA
Cooley & Cooley, Ltd.
Dental · 183d
Cleared Nov 12, 2003
RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES
K031559 · JOW
Renu Medical, Inc.
Cardiovascular · 177d
Cleared Nov 12, 2003
GOOD MORNING TEST
K031798 · LCX
Standard Diagnostics, Inc.
Chemistry · 155d
Cleared Nov 12, 2003
MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881
K031799 · LDS
Miele, Inc.
General Hospital · 155d
Cleared Nov 12, 2003
ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660
K031820 · IPF
Multinational
Physical Medicine · 153d
Cleared Nov 12, 2003
Y.E.S POWERED WHEELCHAIR. T180
K032512 · ITI
Yeou Eir Shuen Machinery Co., Ltd.
Physical Medicine · 90d
Cleared Nov 12, 2003
ENDO PAT 2000
K032519 · DQK
Itamar Medical
Cardiovascular · 89d
Cleared Nov 12, 2003
ORTRAUTEK TRAUMA SYSTEM
K032520 · JEY
Tekka
Dental · 89d
Cleared Nov 12, 2003
WU'S 4-WHEELED SCOOTER, WT-L4JR
K032617 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 79d
Cleared Nov 12, 2003
ULTRADENT CITRIC ACID 10% SOLUTION
K032627 · KJJ
Ultradent Products, Inc.
Dental · 78d
Cleared Nov 12, 2003
ELECSYS PROBNP IMMUNOASSAY
K032646 · NBC
Roche Diagnostics Corp.
Chemistry · 77d
Cleared Nov 12, 2003
Y.E.S. POWERED WHEELCHAIR, MODEL T200
K032669 · ITN
Yeou Eir Shuen Machinery Co., Ltd.
Physical Medicine · 76d
Cleared Nov 12, 2003
MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
K032852 · DRM
Revivant Corp.
Cardiovascular · 61d
Cleared Nov 12, 2003
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
K032861 · LON
bioMerieux, Inc.
Microbiology · 61d
Cleared Nov 12, 2003
KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY...
K033021 · DWJ
Kimberly-Clark Corp.
Cardiovascular · 47d
Cleared Nov 12, 2003
XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
K033066 · OXO
Xitec Holdings, LLC
Radiology · 44d
Cleared Nov 12, 2003
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02
K033097 · ITI
Taiwan King Strong Co., Ltd.
Physical Medicine · 44d
Cleared Nov 12, 2003
COMPACT DIGITAL CARDIAC CAMERA (CDCC)
K033199 · KPS
Is2 Medical Systems, Inc.
Radiology · 41d
Cleared Nov 12, 2003
ESG 4-WHEEL SCOOTER, ESG-03
K033204 · INI
Emg Technology Co., Ltd.
Physical Medicine · 41d
Cleared Nov 12, 2003
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600
K033219 · INI
Tung Keng Enterprise Co., Ltd.
Physical Medicine · 40d