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
108073–108096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1994
BAUSCH & LOMB MEDALIST 66 (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS
K941370 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 66d
Cleared May 27, 1994
ORTHO-JET ACRYLIC RESIN - SPARKLE
K941925 · EBI
Lang Dental Mfg. Co., Inc.
Dental · 37d
Cleared May 27, 1994
STERILE WATER WET DRESSING
K942014 · MGF
Trinity Laboratories, Inc.
General & Plastic Surgery · 31d
Cleared May 27, 1994
EIDOLON ENDOSCOPE COUPLER
K942141 · FET
Eidolon Corp.
Gastroenterology & Urology · 24d
Cleared May 27, 1994
CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676
K942198 · EBZ
Rolence Enterprise Co. , Ltd.
Dental · 22d
Cleared May 27, 1994
REFLEX INS INSUFFLATION NEEDLE
K942207 · HIF
Richard-Allan Medical
Obstetrics & Gynecology · 22d
Cleared May 27, 1994
H-500 ALLIANCE OXYGEN CONCENTRATOR
K942357 · CAW
Healthdyne, Inc.
Anesthesiology · 10d
Cleared May 27, 1994
LORREX GAUZE SPONGES, X-RAY DETECTABLE
K942366 · GDY
Lorrex Health Products
General & Plastic Surgery · 9d
Cleared May 26, 1994
TOTAL CONTAINMENT DEVICE
K913515 · KPF
Denco
Gastroenterology & Urology · 1023d
Cleared May 26, 1994
THERMAPOST ENDODONTIC ROOT CANAL POST
K922931 · ELR
Tulsa Dental Products, Ltd.
Dental · 708d
Cleared May 26, 1994
LPH
K931342 · LRJ
Calgon Vestal Div.
General Hospital · 435d
Cleared May 26, 1994
VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM
K931816 · LRJ
Calgon Vestal Div.
General Hospital · 413d
Cleared May 26, 1994
NON-LINTING DELIVERY BLANKET
K932035 · KNC
Amsco Sterile Recoveries, Inc.
Obstetrics & Gynecology · 394d
Cleared May 26, 1994
FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY
K933767 · HFB
Mahe-Medizintechnik
Obstetrics & Gynecology · 301d
Cleared May 26, 1994
MOLYBDENUM/RHODIUM FILTERS
K934686 · IZO
Continental X-Ray Corp.
Radiology · 239d
Cleared May 26, 1994
INSITE MODEL 20 & MODEL 15 INSUFFLATORS
K934926 · HIF
Andronic Devices, Ltd.
Obstetrics & Gynecology · 224d
Cleared May 26, 1994
INSITE FILTER & TUBING SET
K934928 · HIF
Andronic Devices, Ltd.
Obstetrics & Gynecology · 224d
Cleared May 26, 1994
AQUAPLAST
K935067 · IYE
Wfr/Aquaplast Corp.
Radiology · 218d
Cleared May 26, 1994
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935324 · GZJ
Chattanooga Group, Inc.
Neurology · 202d
Cleared May 26, 1994
LATEX PATIENT EXAMINATION GLOVE
K940022 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 143d
Cleared May 26, 1994
MEDSURG STERILE O.R. TOWELS
K940175 · KKX
Medsurg Industries, Inc.
General Hospital · 135d
Cleared May 26, 1994
WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT
K940288 · JEQ
Teledyne Water Pik
Dental · 125d
Cleared May 26, 1994
FEMININE MAXI PADS
K940468 · HHD
B.A. Wholesale, Inc.
Obstetrics & Gynecology · 113d
Cleared May 26, 1994
POLY BLADES
K940515 · HRX
Linvatec Corp.
Orthopedic · 111d