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
114649–114672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1993
TOSBEE
K914583 · IYD
Toshiba America Medical Systems, In.C
Radiology · 470d
Cleared Jan 28, 1993
HEMOVAC AUTOTRANSFUSION SYSTEM
K920273 · CAC
Zimmer Patient Care Division
Anesthesiology · 372d
Cleared Jan 28, 1993
RS-1 NEUROMUSCULAR STIMULATOR
K920388 · IPF
Rs Medical
Physical Medicine · 364d
Cleared Jan 28, 1993
RS-2 NEUROMUSCULAR STIMULATOR
K920389 · IPF
Rs Medical
Physical Medicine · 364d
Cleared Jan 28, 1993
DIGI -FLOW
K920671 · KOC
D and D Technology, Inc.
Gastroenterology & Urology · 350d
Cleared Jan 28, 1993
ELECTROLINK
K920674 · GXY
Kold Products
Neurology · 349d
Cleared Jan 28, 1993
PERIKON PCL 90
K922294 · HPT
Optikon Oftalmologia Spa
Ophthalmic · 258d
Cleared Jan 28, 1993
IMPLANT-PROPHY & PLASTIC DENTAL INSTRUMENT SYSTEM
K922779 · DZE
Advanced Implant Technologies, Inc.
Dental · 233d
Cleared Jan 28, 1993
AUTOLITH-IEHL
K923822 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 182d
Cleared Jan 28, 1993
POWER SUPPLY
K924021 · JJN
The Binding Site, Ltd.
Hematology · 170d
Cleared Jan 28, 1993
CHOLESTEROL TEST ITEM# 42374/93, 42322/R1
K924508 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 146d
Cleared Jan 28, 1993
NOVA 8 CRT ANALYZER
K924547 · JGS
Nova Biomedical Corp.
Chemistry · 141d
Cleared Jan 28, 1993
DEANS DISPOSABLE T-TUBE INSERTER
K924901 · JYM
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 141d
Cleared Jan 28, 1993
SYSTEM, TOMOGRAPHIC, NUCLEAR
K925330 · KPS
Rjl Associates, LLC
Radiology · 99d
Cleared Jan 28, 1993
MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES
K925364 · BZQ
Merit Medical Systems, Inc.
Anesthesiology · 98d
Cleared Jan 28, 1993
PHOTO CLEARFIL OPAQUER
K925383 · EBF
Kuraray Co.
Dental · 97d
Cleared Jan 28, 1993
ORAL-B DENTAL TAPE WITH FLUORIDE
K925408 · JES
Oral-B Laboratories
Dental · 94d
Cleared Jan 28, 1993
ORAL-B DENTAL FLOSS WITH FLUORIDE
K925409 · JES
Oral-B Laboratories
Dental · 94d
Cleared Jan 28, 1993
SUGAR CHEX LINEARITY FOR THE ONE TOUCH
K925479 · JJX
Streck Laboratories, Inc.
Chemistry · 147d
Cleared Jan 28, 1993
CARDIOBEEPER(R) CB-IIA
K925535 · DXH
Survival Technology, Inc.
Cardiovascular · 87d
Cleared Jan 28, 1993
MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS
K925898 · GZJ
Staodyne, Inc.
Neurology · 69d
Cleared Jan 28, 1993
CLINITEK 200+ URINE CHEMISTRY ANALYZER
K926359 · KQO
Heraeus Kulzer, Inc.
Chemistry · 38d
Cleared Jan 28, 1993
ISE CALIBRATOR FOR DUPONT DIMENSION
K926518 · JIX
Alko Diagnostic Corp.
Chemistry · 29d
Cleared Jan 27, 1993
THE KAUFMANN LIFT-AND-TURN MATTRESS
K915306 · FNM
Kaufmann Sjukvardsartiklar
General Hospital · 433d