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
88873–88896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 1998
GALILEO DISPOSABLE HYSTEROSCOPES
K981828 · HIH
Netoptix Corp.
Obstetrics & Gynecology · 46d
Cleared Jul 07, 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN...
K981883 · CIG
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Jul 07, 1998
UNICAP THYROID PEROXIDASE IGG
K981930 · JZO
Pharmacia & Upjohn Co.
Immunology · 67d
Cleared Jul 06, 1998
SEVRAIN CRANIAL CLAMP
K971252 · GXN
Ikonos Corp.
Neurology · 459d
Cleared Jul 06, 1998
ANSPACH SHIELDED ATTACHMENT
K974025 · GFF
The Anspach Effort, Inc.
General & Plastic Surgery · 256d
Cleared Jul 06, 1998
ADVANTAGE 3D XR
K974715 · JAK
GE Medical Systems
Radiology · 201d
Cleared Jul 06, 1998
IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
K974837 · LPL
Igel Vision Care Pte , Ltd.
Ophthalmic · 194d
Cleared Jul 06, 1998
ADI SYPHILIS RPR LIQUID CONTROLS
K980638 · GMP
Ampcor Diagnostics, Inc.
Microbiology · 137d
Cleared Jul 06, 1998
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K980775 · LPN
Allergan, Inc.
Ophthalmic · 126d
Cleared Jul 06, 1998
ETEST CEFDINIR
K980877 · JWY
Ab Biodisk
Microbiology · 119d
Cleared Jul 06, 1998
CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K981262 · LFL
Valleylab, Inc.
General & Plastic Surgery · 90d
Cleared Jul 06, 1998
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR
K981307 · BTM
International Respiratory Systems, Inc.
Anesthesiology · 87d
Cleared Jul 06, 1998
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH...
K981308 · BTM
International Respiratory Systems, Inc.
Anesthesiology · 87d
Cleared Jul 06, 1998
OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION
K981574 · LPN
Alcon
Ophthalmic · 63d
Cleared Jul 06, 1998
DRAGER-VAPOR 19.3
K981773 · CAD
Draeger Medical, Inc.
Anesthesiology · 47d
Cleared Jul 06, 1998
SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606
K981800 · HIH
Equal Diagnostics, Inc.
Toxicology · 46d
Cleared Jul 06, 1998
CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST
K981882 · MMI
Princeton BioMeditech Corp.
Chemistry · 39d
Cleared Jul 06, 1998
VIGIL HEMOGLOBIN (HBALC) CONTROLS
K982022 · JJX
Beckman Coulter, Inc.
Hematology · 27d
Cleared Jul 02, 1998
NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL...
K973363 · IWI
Ml Strategies, Inc.
Radiology · 297d
Cleared Jul 02, 1998
SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER
K974868 · CBF
Perry Baromedical Corp.
Anesthesiology · 185d
Cleared Jul 02, 1998
OSTEOGRAF/N-300
K981182 · LYC
Ceramed Dental, LLC
Dental · 92d
Cleared Jul 02, 1998
KYPHON INFLATABLE BONE TAMP
K981251 · HRX
Kyphon, Inc.
Orthopedic · 87d
Cleared Jul 02, 1998
ARISTON PHC
K981264 · EBF
Ivoclar USA, Inc.
Dental · 86d
Cleared Jul 02, 1998
ARISTON PHC LINER
K981335 · EMA
Ivoclar North America, Inc.
Dental · 80d