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
100345–100368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 1995
NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES
K953627 · HQY
New Sun Optical Enterprise Co., Ltd.
Ophthalmic · 86d
Cleared Oct 25, 1995
WASHER
K953702 · MBI
Linvatec Corp.
Orthopedic · 78d
Cleared Oct 25, 1995
ELX808 AUTOMATED MICROPLATE READERS
K953710 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 77d
Cleared Oct 25, 1995
AMITA CORPORATION VARIOUS MODELS OF SUNGLASSES
K953744 · HQY
Amita Corp.
Ophthalmic · 93d
Cleared Oct 25, 1995
CHENG CHEN HSING NON-PRESCRIPTION SUNGLASSES
K953808 · HQY
Cheng Chen Hsing Enterp. & Fact. Co....
Ophthalmic · 79d
Cleared Oct 25, 1995
ROCHE REAGENT FOR BUN
K954000 · CDQ
Roche Diagnostic Systems, Inc.
Chemistry · 61d
Cleared Oct 25, 1995
ATH FULL PROFILE ACETABULAR CUP SYSTEM
K954213 · LPH
Kinamed, Inc.
Orthopedic · 48d
Cleared Oct 25, 1995
SINCLAIR NON-PRESCRIPTION SUNGLASSES
K954393 · HQY
Sinclair Corp.
Ophthalmic · 37d
Cleared Oct 25, 1995
BLINDE OPTICS
K954636 · HQY
Blinde Eyewear, Inc.
Ophthalmic · 19d
Cleared Oct 25, 1995
SUNGLASSES
K954639 · HQY
Walmart Stores
Ophthalmic · 15d
Cleared Oct 24, 1995
MITEK ABSORBABLE ANCHOR
K941599 · MNV
Mitek Surgical Products, Inc.
Gastroenterology & Urology · 571d
Cleared Oct 24, 1995
B-FACT, BORDERLINE FACTOR ASSAY CONTROL
K945854 · GGN
George King Bio-Medical, Inc.
Hematology · 344d
Cleared Oct 24, 1995
A-FACT, ABNORMAL FACTOR ASSAY CONTROL
K945855 · GGN
George King Bio-Medical, Inc.
Hematology · 344d
Cleared Oct 24, 1995
HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER
K950004 · DPS
Aerotel, Ltd.
Cardiovascular · 294d
Cleared Oct 24, 1995
B-D PEN ULTRA
K951919 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 183d
Cleared Oct 24, 1995
DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883
K951977 · DXN
Integrated Display Technology, Ltd.
Cardiovascular · 180d
Cleared Oct 24, 1995
CMS URETHRAL WARMER
K952895 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 123d
Cleared Oct 24, 1995
SCINTRON IV
K953193 · KPS
Medical Imaging Electronics America,...
Radiology · 106d
Cleared Oct 24, 1995
NUQUEST NUCLEAR MEDICINE COMPUTER
K953255 · KPS
Sitco, Inc.
Radiology · 104d
Cleared Oct 24, 1995
GUEDEL AIRWAY
K953400 · CAE
Mallinckrodt Medical
Anesthesiology · 96d
Cleared Oct 24, 1995
CANDELA MODEL PLTL-1 LASER SYSTEM
K953412 · GEX
Candela Laser Corp.
General & Plastic Surgery · 96d
Cleared Oct 24, 1995
ULTRASOUND PROBE BIOPSY ACCESSORIES
K953430 · ITX
Biosound, Inc.
Radiology · 95d
Cleared Oct 24, 1995
SIMS BLUE LINE ENDOBRONCHIAL TUBE
K953483 · CBI
Smiths Industries Medical Systems, Inc.
Anesthesiology · 91d
Cleared Oct 24, 1995
PRESSUREGUARD IV
K953503 · FNM
Span-America Medical Systems, Inc.
General Hospital · 90d