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
89377–89400 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 1998
SUGITRON MODEL: IEC
K980177 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 168d
Cleared Jul 07, 1998
CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL)...
K980487 · KRH
Baxter Edwards
Cardiovascular · 148d
Cleared Jul 07, 1998
BIPOLAR FORCEPS SET (MODULAR)
K981321 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 88d
Cleared Jul 07, 1998
CUTALON NYLON POLYAMIDE SURGICAL SUTURE
K981322 · GAR
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 88d
Cleared Jul 07, 1998
ANU ICE
K981428 · LKX
Cryoptherapy Pain Relief Products, Inc.
Gastroenterology & Urology · 78d
Cleared Jul 07, 1998
IL TEST PT-FIBRINOGEN RECOMBINANT
K981479 · GJS
Instrumentation Laboratory CO
Hematology · 74d
Cleared Jul 07, 1998
GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION
K981488 · LYZ
Oak Carolina, Inc.
General Hospital · 71d
Cleared Jul 07, 1998
UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY
K981559 · JZO
Pharmacia & Upjohn Co.
Immunology · 67d
Cleared Jul 07, 1998
ACS:CENTAUR AFP
K981592 · LOQ
Chiron Diagnostics Corp.
Immunology · 64d
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