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
102865–102888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1995
PADGETT AIR DERMATOME, MODEL A
K951085 · GFD
Padgett Instruments, Inc.
General & Plastic Surgery · 67d
Cleared May 15, 1995
BIOPSY DEVICE ACCESSORY
K951326 · BTA
Biopsys Medical, Inc.
General & Plastic Surgery · 53d
Cleared May 15, 1995
SIRESKOP SX
K951358 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 52d
Cleared May 15, 1995
KODAK X-OMAT 3000 RA PROCESSOR
K951396 · IXW
Eastman Kodak Company
Radiology · 49d
Cleared May 15, 1995
KODAK X-OMAT 5000 RA PROCESSOR
K951397 · IXW
Eastman Kodak Company
Radiology · 49d
Cleared May 15, 1995
AMERICAN DENTAL PRODUCTS (ADP), COMPOSITE RESTORATIVE MATERIAL
K951427 · EBF
American Dental Products, Inc.
Dental · 49d
Cleared May 15, 1995
ACE AMYLASE REAGENT
K951548 · JFJ
Schiapparelli Biosystems, Inc.
Chemistry · 41d
Cleared May 15, 1995
T-UPTAKE EIA TEST
K951586 · KHQ
Diagnostic Reagents, Inc.
Chemistry · 39d
Cleared May 15, 1995
BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN...
K951635 · DEW
Beckman Instruments, Inc.
Immunology · 38d
Cleared May 15, 1995
COAT-A-COUNT LH IRMA
K951748 · CEP
Diagnostic Products Corp.
Chemistry · 28d
Cleared May 15, 1995
BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3
K951749 · JJY
Biocell Laboratories, Inc.
Chemistry · 28d
Cleared May 15, 1995
HICHEM ALT REAGENT KIT
K951818 · CKA
Hi Chem, Inc.
Chemistry · 25d
Cleared May 15, 1995
KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE
K951826 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 25d
Cleared May 15, 1995
NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER
K951907 · GBX
Navarre Biomedical , Ltd.
General & Plastic Surgery · 21d
Cleared May 15, 1995
HYDRACARE ABSORBENT WOUND DRESSING
K951914 · KMF
Acacia Laboratories, Inc.
General & Plastic Surgery · 21d
Cleared May 12, 1995
CMS SYSTEM
K922528 · DQK
Micromedical Industries, Ltd.
Cardiovascular · 1079d
Cleared May 12, 1995
COBE CENTRYSYSTEM CS500 DIALYZER
K941708 · FJI
C.G.H. Medical, Inc.
Gastroenterology & Urology · 401d
Cleared May 12, 1995
NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000
K942347 · DQA
Nellcor, Inc.
Anesthesiology · 360d
Cleared May 12, 1995
DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER
K943215 · EWO
Kenneth Ullrich
Ear, Nose, Throat · 311d
Cleared May 12, 1995
DI-2000
K943602 · IYX
Miles Inc., Agfa Division
Radiology · 291d
Cleared May 12, 1995
MICRO MULTILEAF COLLIMATOR
K943714 · IYE
Leibinger F.L. Fischer
Radiology · 284d
Cleared May 12, 1995
MRH-1500
K943798 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 282d
Cleared May 12, 1995
NON-CONTACT TONOMETER T-2
K943939 · HKX
Canon, Inc.
Ophthalmic · 273d
Cleared May 12, 1995
PACS EQUIPMENT
K943994 · LMD
Rstar Image Management System
Radiology · 269d