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
108097–108120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 1994
PATIENT EXAMINATION GLOVES
K940576 · LYY
Vijay Latex Products Private , Ltd.
General Hospital · 107d
Cleared May 26, 1994
1ML LUER-LOK SYRINGE
K941562 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 55d
Cleared May 26, 1994
BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE
K941657 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 51d
Cleared May 26, 1994
DISPOSABLE FILTERED INSUFFLATION TUBING SET
K941685 · HIF
Blue Planet Industries, Inc.
Obstetrics & Gynecology · 50d
Cleared May 26, 1994
DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR
K941931 · KPR
Victoreen, Inc.
Radiology · 36d
Cleared May 26, 1994
ALDEN WHEELCHAIR CUSHION
K942260 · KNN
Ward and Assoc.
Physical Medicine · 17d
Cleared May 26, 1994
ALDEN LINEAGE WHEELCHAIR CUSHION
K942312 · KNN
Lewis W. Ward
Physical Medicine · 13d
Cleared May 25, 1994
THERAC 25
K922276 · IYE
Theratronics, Inc.
Radiology · 740d
Cleared May 25, 1994
OWENS BIOPSY FORCEPS
K926595 · HFB
Owens Industries, Inc.
Obstetrics & Gynecology · 623d
Cleared May 25, 1994
HYDROT
K930918 · ILO
Sanker Intl., Inc.
Physical Medicine · 462d
Cleared May 25, 1994
URETERAL CATHETER AND ACCESSORIES
K934419 · EYK
Urological Associates of Central...
Gastroenterology & Urology · 254d
Cleared May 25, 1994
DG 3P SYSTEM
K934670 · GWQ
Medelec , Ltd.
Neurology · 238d
Cleared May 25, 1994
KERATOPLASTY SUTURING LENS
K940106 · HPX
Visionary Technologies of Miami, Inc.
Ophthalmic · 135d
Cleared May 25, 1994
LAPAROSCOPY DILATION SYSTEM
K942201 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 20d
Cleared May 25, 1994
SUCTION AND IRRIGATION TUBES
K942202 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 20d
Cleared May 24, 1994
CERVEX-BRUSH
K930955 · HHT
Rovers B.V.
Obstetrics & Gynecology · 455d
Cleared May 24, 1994
HYDRAGOWN
K934664 · FYA
Mallinckrodt Group, Inc.
General Hospital · 238d
Cleared May 24, 1994
SARNS ULTRASONIC AIR SENSOR
K940651 · KRL
3M Health Care, Sarns
Cardiovascular · 98d
Cleared May 24, 1994
SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
K940795 · DYG
Baxter Edwards
Cardiovascular · 91d
Cleared May 24, 1994
FLUTTER(R)
K940986 · BYI
Varioraw SA
Anesthesiology · 84d
Cleared May 24, 1994
SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY
K941497 · CKA
Solarcare, Inc.
Chemistry · 57d
Cleared May 24, 1994
GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT
K941660 · KYH
Gm Engineering, Inc.
Ophthalmic · 49d
Cleared May 24, 1994
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
K941895 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 36d
Cleared May 24, 1994
SURGITEK INFUSER
K941952 · FAD
Surgitek
Gastroenterology & Urology · 32d