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
95545–95568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 1996
VITALMAX 4000/MINIPACK 3100/3000
K951226 · DSK
Pace Tech, Inc.
Cardiovascular · 612d
Cleared Nov 21, 1996
BACTEC FUNGAL MEDIUM
K954923 · JTA
Becton Dickinson Diagnostic...
Microbiology · 392d
Cleared Nov 21, 1996
GEMINI PC-ITX
K960512 · FRN
Imed Corp.
General Hospital · 290d
Cleared Nov 21, 1996
SPEED-CUT
K961407 · KNW
Gallini Intl., Inc.
Gastroenterology & Urology · 224d
Cleared Nov 21, 1996
TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)
K962128 · DXG
Hemo Sapiens, Inc.
Cardiovascular · 171d
Cleared Nov 21, 1996
EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
K962389 · BTR
Unomedical Sdn Bhd
Anesthesiology · 154d
Cleared Nov 21, 1996
ENDO VIP
K963323 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 90d
Cleared Nov 21, 1996
DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC...
K963344 · FAM
Vision-Sciences, Inc.
Gastroenterology & Urology · 87d
Cleared Nov 21, 1996
COMFOR FOAM LIMB HOLDERS- SINGLE STRAP
K963462 · FMQ
Bird & Cronin, Inc.
General Hospital · 79d
Cleared Nov 21, 1996
24448-010 SECURE-ALL FINGER CONTROL MITT
K963554 · FMQ
Tecnol Medical Products, Inc.
General Hospital · 77d
Cleared Nov 21, 1996
SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)
K963556 · FMQ
Tecnol Medical Products, Inc.
General Hospital · 77d
Cleared Nov 21, 1996
SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030
K963557 · FMQ
Tecnol Medical Products, Inc.
General Hospital · 77d
Cleared Nov 21, 1996
ULTRA CARE VEST STYLE BODY HOLDER, SMALL...
K963561 · FMQ
Tecnol Medical Products, Inc.
General Hospital · 77d
Cleared Nov 21, 1996
ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES,...
K963563 · FMQ
Tecnol Medical Products, Inc.
General Hospital · 77d
Cleared Nov 21, 1996
RADIONICS SLUIJTER-MEHTA CANNULA
K963577 · GXD
Radionics, Inc.
Neurology · 76d
Cleared Nov 21, 1996
VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT...
K963611 · DXZ
Vascutek, Ltd.
Cardiovascular · 72d
Cleared Nov 21, 1996
24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT
K963773 · FMQ
Tecnol Medical Products, Inc.
General Hospital · 63d
Cleared Nov 21, 1996
N PROTEIN STRANDARD SL
K964062 · JIX
Behring Diagnostics, Inc.
Chemistry · 42d
Cleared Nov 20, 1996
FLAVORED LATEX PATIENT EXAMINATION
K960315 · LYY
P.T. Irama Dinamika Latex
General Hospital · 302d
Cleared Nov 20, 1996
METRO FOCAL ASPHERIC (POLYMACON)
K961606 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 209d
Cleared Nov 20, 1996
MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)
K961917 · DQX
Medtronics Interventional Vascular
Cardiovascular · 187d
Cleared Nov 20, 1996
LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR...
K963010 · HQD
Permeable Technologies, Inc.
Ophthalmic · 110d
Cleared Nov 20, 1996
TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
K963327 · CCK
Novametrix Medical Systems, Inc.
Anesthesiology · 89d
Cleared Nov 20, 1996
SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHILIC)CONTACT LENS...
K963488 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 78d