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
101521–101544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1995
USCI INPUT INTRODUCER SET
K940092 · DYB
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 580d
Cleared Aug 10, 1995
STRYKER OPERATING LAPAROSCOPE
K943100 · HET
Stryker Endoscopy
Obstetrics & Gynecology · 407d
Cleared Aug 10, 1995
PLASMA ARC CURING SYSTEM
K952333 · EBF
American Dental Technologies, Inc.
Dental · 84d
Cleared Aug 10, 1995
EZ-COMP
K952353 · EBF
Adm, Inc.
Dental · 83d
Cleared Aug 10, 1995
AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
K952748 · LJT
United States Surgical, A Division of...
General Hospital · 55d
Cleared Aug 10, 1995
DILATATION CATHETER, BALLOON
K952968 · LJE
Boston Scientific Corp
Gastroenterology & Urology · 44d
Cleared Aug 09, 1995
PERIPUMP
K934552 · HIR
Deschutes Medical Products, Inc.
Gastroenterology & Urology · 687d
Cleared Aug 09, 1995
DURACON BASEPLATES
K936008 · JWH
Howmedica Corp.
Orthopedic · 601d
Cleared Aug 09, 1995
SECURE-SITE
K941098 · KMK
Op-Co Medical Products , Ltd.
General Hospital · 518d
Cleared Aug 09, 1995
MEDRAD QWIK-FIX MRI DISPOSABLE KIT
K943189 · LNH
Medrad, Inc.
Radiology · 400d
Cleared Aug 09, 1995
ACU-HALT
K945374 · LDQ
Eva-Health USA, Inc.
General & Plastic Surgery · 280d
Cleared Aug 09, 1995
SIGNA PROFILE
K945730 · LNH
GE Medical Systems
Radiology · 260d
Cleared Aug 09, 1995
OSTEONICS RESTORATION MONOLITHIC HIP STEM
K951291 · MEH
Osteonics Corp.
Orthopedic · 156d
Cleared Aug 09, 1995
STRICKLAND TRAPEZIAL IMPLANT
K951471 · KYI
Wrightmedicaltechnologyinc
Orthopedic · 132d
Cleared Aug 09, 1995
MED-TEC REDISET
K952189 · IYE
Medtec, Inc.
Radiology · 92d
Cleared Aug 09, 1995
ALCON SERIES 20000 LEGACY PHACOEMULSIFIER
K952213 · HQC
Alcon Laboratories
Ophthalmic · 90d
Cleared Aug 09, 1995
SERIM HISENSE TEST KIT
K952215 · FIP
Serim Research Corp.
Gastroenterology & Urology · 90d
Cleared Aug 09, 1995
OKAMOTO CONDOM
K952393 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 79d
Cleared Aug 09, 1995
TRACHEOSTOMY CARE KIT
K952416 · BTO
Medi-Flex Hospital Products, Inc.
Anesthesiology · 78d
Cleared Aug 09, 1995
KARL STORZ ENDOSCOPY POWDER BLOWER
K952443 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 76d
Cleared Aug 09, 1995
ALALYSIS PACKAGE FOR DENTAL APPLICATIONS FOR XPEED, XPRESS, XVISION
K953164 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 33d
Cleared Aug 09, 1995
ECTRA LIGAMENT RELEASE SYSTEM
K953387 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 21d
Cleared Aug 09, 1995
UNSCENTED MENSTRUAL SHIELD
K953487 · HHD
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 15d
Cleared Aug 09, 1995
UNSCENTED MENSTRUAL LINER
K953488 · HHD
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 15d