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
95713–95736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1996
CASS SYSTEM (MODIFICATION)
K961484 · IYE
Medical Instrumentation & Diagnostics...
Radiology · 223d
Cleared Nov 07, 1996
INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
K961593 · LRB
Segi Hearing Aid Co.
Ear, Nose, Throat · 197d
Cleared Nov 07, 1996
CATH SEAL
K962180 · DYB
Universal Medical Instrument Corp.
Cardiovascular · 154d
Cleared Nov 07, 1996
HEARTPORT CABLE BULLDOG CLAMP
K962366 · DXC
Heartport, Inc.
Cardiovascular · 141d
Cleared Nov 07, 1996
CINCH QR SGW EXTENSION
K963171 · DQX
Cordis Corp.
Cardiovascular · 85d
Cleared Nov 07, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K963179 · LNH
GE Medical Systems
Radiology · 85d
Cleared Nov 07, 1996
VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR
K963247 · NFB
Thermadyne Holings Corp.
Anesthesiology · 80d
Cleared Nov 07, 1996
BEST STRAP RESTRAINT
K963371 · FMQ
Morrison Medical Products
General Hospital · 72d
Cleared Nov 07, 1996
HEELBO ER WRIST RESTRAINT
K963372 · FMQ
Heelbo, Inc.
General Hospital · 72d
Cleared Nov 07, 1996
KARL STORZ CONTACT MICRO-LARYNGOSCOPES
K963426 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 69d
Cleared Nov 07, 1996
CARDIAC STATUS TROPONIN I
K963513 · MMI
Princeton BioMeditech Corp.
Chemistry · 65d
Cleared Nov 07, 1996
DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT
K963525 · DBL
Shield Diagnostics, Ltd.
Immunology · 64d
Cleared Nov 07, 1996
IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP]...
K963592 · LMD
Dejarnette Research Systems
Radiology · 59d
Cleared Nov 07, 1996
IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM...
K963594 · LMD
Dejarnette Research Systems
Radiology · 59d
Cleared Nov 07, 1996
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
K963628 · LMD
Dejarnette Research Systems
Radiology · 57d
Cleared Nov 07, 1996
FIBRE INTERSPACED X-RAY GRID
K963893 · IXJ
Smit Rontgen
Radiology · 41d
Cleared Nov 07, 1996
NATURALE HCG PREGNANCY TES
K964002 · LCX
Mizuho USA, Inc.
Chemistry · 31d
Cleared Nov 07, 1996
STP SYSTEM - SAF
K964026 · LIO
Sage Products, Inc.
Microbiology · 31d
Cleared Nov 07, 1996
IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING...
K964113 · EMX
M-Pact Worldwide Management Corp.
Ear, Nose, Throat · 23d
Cleared Nov 07, 1996
EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE
K964263 · KGI
Lunar Corp.
Radiology · 13d
Cleared Nov 06, 1996
FLEXSURE OBT
K961062 · KHE
Smithkline Diagnostics, Inc.
Hematology · 233d
Cleared Nov 06, 1996
WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL
K961292 · JOW
Wright Linear Pump, Inc.
Cardiovascular · 216d
Cleared Nov 06, 1996
WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE
K961797 · JOW
Wright Linear Pump, Inc.
Cardiovascular · 181d
Cleared Nov 06, 1996
WLP SINGLE-SEGMENT VERSION WLP SOLO VII
K961891 · JOW
Wright Linear Pump, Inc.
Cardiovascular · 181d