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
72145–72168 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2003
IGI-SYSTEM
K023424 · HAW
Denx Advanced Dental Systems
Neurology · 210d
Cleared May 09, 2003
OPAQUE HERRICK LACRIMAL PLUG
K030300 · LZU
Lacrimedics, Inc.
Ophthalmic · 100d
Cleared May 09, 2003
DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE),...
K030417 · LDD
Philips Medical Systems
Cardiovascular · 88d
Cleared May 09, 2003
POWERLITE 600 EP SYSTEM
K030423 · GEX
Preswede AB
General & Plastic Surgery · 88d
Cleared May 09, 2003
MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
K030443 · KNW
Nastech Pharmaceutical Company, Inc.
Gastroenterology & Urology · 87d
Cleared May 09, 2003
OSTEOMED 2.0 LOCKING PLATES AND SCREWS
K030448 · JEY
Osteomed LP
Dental · 87d
Cleared May 09, 2003
LAPAROSHIELD CONDITIONED INSUFFLATION SET
K030469 · HIF
Pall Medical
Obstetrics & Gynecology · 86d
Cleared May 09, 2003
DEPILASE YAG LASE PLUS LASER SYSTEM
K030506 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 79d
Cleared May 09, 2003
MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A
K030561 · DXN
Mytech Technology Co., Ltd.
Cardiovascular · 77d
Cleared May 09, 2003
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR
K030680 · JOJ
Spsmedical Supply Corp.
General Hospital · 65d
Cleared May 09, 2003
ETCHANT 40%
K030743 · KLE
Confi-Dental Products Co.
Dental · 60d
Cleared May 09, 2003
MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL
K030776 · ELW
Discus Dental, Inc.
Dental · 59d
Cleared May 09, 2003
STACKED ABR FOR NAVIGATOR PRO
K030907 · GWJ
Bio-Logic Systems Corp.
Neurology · 46d
Cleared May 09, 2003
C3 PATIENT MONITOR
K030931 · MHX
Analogic Corp.
Cardiovascular · 45d
Cleared May 09, 2003
AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)
K031008 · HBA
Aesculap
Neurology · 39d
Cleared May 09, 2003
NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005
K031156 · HAW
Orthosoft, Inc.
Neurology · 28d
Cleared May 09, 2003
SMARTXIDE
K031224 · GEX
Cynosure, Inc.
General & Plastic Surgery · 22d
Cleared May 09, 2003
QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424
K031289 · ITI
Sunrise Medical, Inc.
Physical Medicine · 16d
Cleared May 09, 2003
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K031293 · LYZ
Shijiazhuang Eversharp Plastic...
General Hospital · 16d
Cleared May 09, 2003
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
K031347 · ODG
Olympus Optical Co., Ltd.
Radiology · 10d
Cleared May 09, 2003
TRANSVAGINAL DOPPLER PROBE
K031358 · ITX
Vascular Control Systems, Inc.
Radiology · 9d
Cleared May 08, 2003
HEADFIX
K030439 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 86d
Cleared May 08, 2003
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344,...
K030573 · JKA
Bd Vacutainer Systems Preanalyical...
Chemistry · 73d
Cleared May 08, 2003
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
K031056 · MOS
Usa Instruments, Inc.
Radiology · 35d