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
76393–76416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2002
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
K013870 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 57d
Cleared Jan 17, 2002
SIMPLICITY STARPLUS SOFT INFUSION SET
K014061 · FPA
Sterling Medivations, Inc.
General Hospital · 38d
Cleared Jan 17, 2002
SIMPLICITY EASY ACCESS INFUSION SET
K014062 · FPA
Sterling Medivations, Inc.
General Hospital · 38d
Cleared Jan 17, 2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY...
K014136 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 31d
Cleared Jan 17, 2002
MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM,...
K014145 · MQP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Jan 17, 2002
SELF-DRILLING RADIOGRAPHIC MARKER
K014148 · NEU
Walter Lorenz Surgical, Inc.
General & Plastic Surgery · 30d
Cleared Jan 17, 2002
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
K014157 · MKJ
Philips Medical Systems
Cardiovascular · 29d
Cleared Jan 17, 2002
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K014194 · KTT
Ebi, L.P.
Orthopedic · 27d
Cleared Jan 17, 2002
BARD CONQUEST PTA BALLOON DILATATION CATHETER
K014212 · DQY
C.R. Bard, Inc.
Cardiovascular · 27d
Cleared Jan 17, 2002
SIEMENS INFINITY GATEWAY SUITE
K014213 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 27d
Cleared Jan 17, 2002
BREATHTEK - UBIT UBT FOR H. PYLORI
K014225 · MSQ
Meretek Diagnostics, Inc.
Microbiology · 22d
Cleared Jan 17, 2002
MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND:...
K014234 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 22d
Cleared Jan 16, 2002
LUMEND PERCUTANEOUS CATHETER
K011562 · DQY
Lumend, Inc.
Cardiovascular · 240d
Cleared Jan 16, 2002
OSTEOMED BIORESORBABLE FIXATION SYSTEM
K012486 · DZL
Osteomed Corp.
Dental · 167d
Cleared Jan 16, 2002
KONICA LASER IMAGER, DRYPRO MODEL 751/752
K013052 · LMC
Konica Minolta Medical & Graphic, Inc.
Radiology · 127d
Cleared Jan 16, 2002
SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9
K013560 · KGO
Semperit Technische Produkte Gesellshaft
General Hospital · 82d
Cleared Jan 16, 2002
NEXUS 2 CLEAR
K013609 · EMA
Sybron Dental Specialties, Inc.
Dental · 77d
Cleared Jan 16, 2002
REVOLUTION FORMULA 2
K013647 · EBF
Sybron Dental Specialties, Inc.
Dental · 72d
Cleared Jan 16, 2002
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
K013656 · IZH
Planmed OY
Radiology · 71d
Cleared Jan 16, 2002
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC...
K013833 · DQX
Guidant Corp.
Cardiovascular · 58d
Cleared Jan 16, 2002
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 58d
Cleared Jan 16, 2002
HL168E
K014122 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Jan 16, 2002
NUMED COEFFICIENT PTV CATHETERS
K014124 · OMZ
NuMED, Inc.
Cardiovascular · 30d
Cleared Jan 16, 2002
MODIFICATION TO EBI OMEGA 21 SYSTEM
K014137 · MNH
Ebi, L.P.
Orthopedic · 30d