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
90865–90888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1997
ELECTRODE, ELECTROCARDIOGRAPH
K973727 · DRX
Don Tay Industries
Cardiovascular · 80d
Cleared Dec 19, 1997
MIDSTREAM HOME REGNANCY TEST
K973825 · DHA
Germaine Laboratories, Inc.
Chemistry · 73d
Cleared Dec 19, 1997
KOLPLAST VAGINAL SPECULUM
K973853 · HIB
Kolplast Comercial E Industrial Ltda
Obstetrics & Gynecology · 72d
Cleared Dec 19, 1997
PROPHYFLEX 2, MODEL 2012
K973876 · EFB
Kavo America
Dental · 70d
Cleared Dec 19, 1997
AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT...
K973893 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 66d
Cleared Dec 19, 1997
ORTHOFIX FEMORAL NAILING SYTEM
K973944 · HSB
Orthofix Srl
Orthopedic · 64d
Cleared Dec 19, 1997
CERCLAGE CABLE WITH HEX BUTTON
K974016 · JDQ
Pioneer Surgical Technology
Orthopedic · 58d
Cleared Dec 19, 1997
SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM
K974020 · JDQ
Spinal Concepts, Inc.
Orthopedic · 58d
Cleared Dec 19, 1997
SIGNAL PREGNANCY TEST KIT
K974021 · LCX
Sa Scientific, Inc.
Chemistry · 58d
Cleared Dec 19, 1997
AMSURE CLEANSING ENEMA SET
K974042 · FCE
Amsino Intl., Inc.
Gastroenterology & Urology · 56d
Cleared Dec 19, 1997
QUICKVUE SEMI-Q HCG-COMBO
K974052 · JHI
Quidel Corp.
Chemistry · 53d
Cleared Dec 19, 1997
HYDRA METER
K974127 · FIP
Automata Instrumentation, Inc.
Gastroenterology & Urology · 46d
Cleared Dec 19, 1997
CHOICE ACCU-TEST PREGNANCY TEST KIT
K974154 · LCX
Sa Scientific, Inc.
Chemistry · 45d
Cleared Dec 19, 1997
COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS
K974171 · KZH
Teva Medical, Ltd.
General Hospital · 44d
Cleared Dec 19, 1997
MICROPROTEIN STANDARD KIT
K974290 · JIX
Verichem Laboratories, Inc.
Chemistry · 35d
Cleared Dec 19, 1997
TELEMED SYSTEMS RETRIEVAL BASKET
K974300 · OCZ
Telemed Systems, Inc.
Gastroenterology & Urology · 32d
Cleared Dec 18, 1997
BOUSER'S URINAL
K970465 · EXJ
General Polymers
Gastroenterology & Urology · 314d
Cleared Dec 18, 1997
SHANG HO
K970795 · KGO
Shang HO Industrial Corp. , Ltd.
General Hospital · 289d
Cleared Dec 18, 1997
SNOREX
K971818 · LQZ
Snorex (Nz) , Ltd.
Dental · 216d
Cleared Dec 18, 1997
LATERAL FLARE INTERNAL COLLAR (LFIC)
K971900 · LWJ
Pro-Lfic, LLC
Orthopedic · 209d
Cleared Dec 18, 1997
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
K973284 · CHH
Roche Diagnostic Systems, Inc.
Chemistry · 107d
Cleared Dec 18, 1997
IDA-4 AND IPT-MC
K973609 · FRN
Bio-Tek Instruments, Inc.
General Hospital · 87d
Cleared Dec 18, 1997
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES
K973614 · KWL
Encore Orthopedics, Inc.
Orthopedic · 86d
Cleared Dec 18, 1997
FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA
K973672 · JWH
Encore Orthopedics, Inc.
Orthopedic · 83d