FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91369–91392 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1997
VALLEY FORGE BIPOLAR BALL TIP ELECTRODE
K973554 · JOS
Valley Forge Scientific Corp.
General & Plastic Surgery · 91d
Cleared Dec 19, 1997
THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM
K973595 · JWH
Corin USA
Orthopedic · 88d
Cleared Dec 19, 1997
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM
K973603 · GEX
Schwartz Electro-Optics, Inc.
General & Plastic Surgery · 88d
Cleared Dec 19, 1997
SKYVAL
K973610 · FYD
Pyramid Air Systems
General Hospital · 88d
Cleared Dec 19, 1997
SOMNOPLASTY SYSTEM
K973618 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 87d
Cleared Dec 19, 1997
NATURAL-HIP POROUS STEM WITH OFFSET
K973675 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 19, 1997
NATURAL-HIP COCR OFFSET STEM
K973681 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 19, 1997
REVELATION POROUS HIP STEM
K973685 · LPH
Encore Orthopedics, Inc.
Orthopedic · 84d
Cleared Dec 19, 1997
TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL
K973708 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 81d
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