FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
130897–130920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1989
SPIN-CLEAN CLEANING UNIT
K892372 · LYL
Willmar Contact Lens Co.
Ophthalmic · 78d
Cleared Jun 23, 1989
NSD 8CS8 - TENS DEVICE
K892408 · GZJ
Future Medical Products, Inc.
Neurology · 77d
Cleared Jun 23, 1989
KENDALL KENGUARD URINARY LEG BAGS
K892437 · KNX
The Kendal Co.
Gastroenterology & Urology · 74d
Cleared Jun 23, 1989
KENDALL CURITY STOMACH TUBES
K892439 · KNT
The Kendal Co.
Gastroenterology & Urology · 74d
Cleared Jun 23, 1989
KENDALL CURITY URETHRAL CATHETERS
K892442 · GBM
The Kendal Co.
Gastroenterology & Urology · 74d
Cleared Jun 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892566 · LYY
Foodhandler, Inc.
General Hospital · 74d
Cleared Jun 23, 1989
SENSIMAT
K892657 · IZO
Transworld X-Ray Corp.
Radiology · 71d
Cleared Jun 23, 1989
CATHETERS, MALE, FEMALE
K892691 · KOD
Zinnanti Surgical Instruments, Inc.
Gastroenterology & Urology · 71d
Cleared Jun 23, 1989
THE STAGO VIII DEFICIENT PLASMA KIT
K892859 · GGP
American Bioproducts Co.
Hematology · 66d
Cleared Jun 23, 1989
SATURNE 41
K892860 · IYE
General Electric Co.
Radiology · 66d
Cleared Jun 23, 1989
DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101
K892881 · EHZ
Nieusma R & D, Inc.
Dental · 78d
Cleared Jun 23, 1989
DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102
K892882 · EHZ
Nieusma R & D, Inc.
Dental · 78d
Cleared Jun 23, 1989
BREATH TRACKER
K892942 · CAP
Core-M, Inc.
Anesthesiology · 63d
Cleared Jun 23, 1989
DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET
K893140 · JJX
Casco Standards
Chemistry · 59d
Cleared Jun 23, 1989
DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET
K893141 · JJY
Casco Standards
Chemistry · 59d
Cleared Jun 23, 1989
DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET
K893142 · JJY
Casco Standards
Chemistry · 59d
Cleared Jun 23, 1989
DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM
K893388 · BYE
Devilbiss Health Care, Inc.
Anesthesiology · 53d
Cleared Jun 23, 1989
MI-328, MI-316, MI-388 DIGITAL THERMOMETER
K893391 · FLL
Nam Tai Electronic & Electrical...
General Hospital · 53d
Cleared Jun 23, 1989
AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM
K893396 · DYH
American Orthodontics
Dental · 53d
Cleared Jun 23, 1989
SERUMAX (AUTOMATED SERUM CENTRIFUGATION & STATION)
K893400 · JQW
Medical Robotics
Chemistry · 53d
Cleared Jun 23, 1989
COMPACT 2052(TM) DUAL COLLECTION BLOOD RECOVERY
K893402 · CAC
Atrium Medical Corp.
Anesthesiology · 53d
Cleared Jun 23, 1989
URIC ACID REAGENT (PROCEDURE NUMBER 686)
K893416 · KNK
Sigma Chemical Co.
Chemistry · 52d
Cleared Jun 23, 1989
MASTERLAB PFT AND MASTERLAB BODY BOX
K893420 · CCM
Quinton, Inc.
Anesthesiology · 57d
Cleared Jun 23, 1989
CLEARVIEW STREP A
K893422 · GTZ
Unipath , Ltd.
Microbiology · 52d