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
109345–109368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1994
MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY
K934700 · OXO
Tempo Technology, Inc.
Radiology · 167d
Cleared Mar 16, 1994
AUTOSUTURE ENDOSCOPIC SUTURING DEVICE
K934738 · OCW
United States Surgical, A Division of...
Gastroenterology & Urology · 166d
Cleared Mar 16, 1994
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670
K935304 · LWM
3M Company
Dental · 134d
Cleared Mar 16, 1994
NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM
K935570 · LNH
Resonex, Inc.
Radiology · 118d
Cleared Mar 16, 1994
PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER
K935580 · OXO
Precise Optics
Radiology · 118d
Cleared Mar 16, 1994
MAGNETOM OPEN
K935661 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 110d
Cleared Mar 16, 1994
FAST SPIN ECHO
K935664 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 110d
Cleared Mar 16, 1994
TC+ SYSTEM (TILTING C-ARM SYSTEM)
K936180 · OWB
GE Medical Systems
Radiology · 79d
Cleared Mar 16, 1994
SHIMADZU MOBILE X-RAY SYSTEMS
K940294 · OXO
Shimadzu Precision Instruments, Inc.
Radiology · 54d
Cleared Mar 16, 1994
STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM
K940539 · KPY
Standard Imaging, Inc.
Radiology · 37d
Cleared Mar 16, 1994
TROCAR
K940687 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 28d
Cleared Mar 16, 1994
SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5
K940696 · KXJ
Philips Medical Systems North...
Radiology · 28d
Cleared Mar 15, 1994
BARD UROTRACK II MONITORING
K924436 · KOC
C.R. Bard, Inc.
Gastroenterology & Urology · 560d
Cleared Mar 15, 1994
SULLIVAN III NASAL CPAP SYSTEM
K930656 · BZD
Rescare , Ltd.
Anesthesiology · 399d
Cleared Mar 15, 1994
ORION DIAGNOSTIC ULTRASOUND SYSTEM
K930768 · IYO
GE Medical Systems
Radiology · 392d
Cleared Mar 15, 1994
PROTECTOR INTRODUCER SHEATH
K930808 · DYB
Boston Scientific /International...
Cardiovascular · 392d
Cleared Mar 15, 1994
MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER
K931205 · HHI
Baxter Healthcare Corp
Obstetrics & Gynecology · 371d
Cleared Mar 15, 1994
CANDELA SPTL PULSED DYE LASERS
K931762 · GEX
Candela Laser Corp.
General & Plastic Surgery · 341d
Cleared Mar 15, 1994
PATIENT EXAMINATION GLOVES (POWDER FREE)
K932116 · LYY
Evergrade Healthcare Products Sdn Bhd
General Hospital · 316d
Cleared Mar 15, 1994
SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN
K932266 · KGE
Symbiosis Corp.
Gastroenterology & Urology · 329d
Cleared Mar 15, 1994
PATIENT EXAMINATION GLOVE - POWDERED
K932332 · LYY
Sj Medical Products (M) Sdn Bhd
General Hospital · 306d
Cleared Mar 15, 1994
POWERED MUSCLE STIMULATOR
K932898 · IPF
Nemectron GmbH
Physical Medicine · 274d
Cleared Mar 15, 1994
SLIMFLEX - POWDER FREE LATEX EXAMINATION GLOVES
K933224 · LYY
Slim River Latex Sdn. Bhd.
General Hospital · 257d
Cleared Mar 15, 1994
TURBO II
K933402 · FNM
Kinetic Concepts, Inc.
General Hospital · 246d