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
121489–121512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1991
GLOBAL CARE MICRO II
K910244 · GZJ
Globalcare Intl., Inc.
Neurology · 168d
Cleared Jul 09, 1991
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K910610 · JEQ
Bausch & Lomb, Inc.
Dental · 147d
Cleared Jul 09, 1991
ABL520 BLOOD GAS SYSTEM
K910827 · GHS
Radiometer America, Inc.
Hematology · 132d
Cleared Jul 09, 1991
NHS 2044P BODY AID, HEARING AID
K911183 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 113d
Cleared Jul 09, 1991
ILCO INFRARED LIGHT COAGULATOR
K911600 · KNS
Holl Meditronics, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 09, 1991
TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES
K911605 · DQO
Target Therapeutics
Cardiovascular · 90d
Cleared Jul 09, 1991
BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES
K911606 · KDD
Baxter Healthcare Corp
General & Plastic Surgery · 90d
Cleared Jul 09, 1991
CAPIOX(R) BUBBLE TRAP
K911632 · KRL
Terumo Medical Corp.
Cardiovascular · 89d
Cleared Jul 09, 1991
ABIODENT PERIOTEMP(R) SYSTEM
K911643 · EIL
Abiomed, Inc.
Dental · 88d
Cleared Jul 09, 1991
COULTERCLONE
K911793 · GKZ
Coulter Immunology
Hematology · 78d
Cleared Jul 09, 1991
SPACE(TM) 7500
K912071 · IKN
F.M. Wiest USA, Inc.
Gastroenterology & Urology · 60d
Cleared Jul 09, 1991
FX-CABLELOK SYSTEM
K912207 · JDQ
Biodynamic Technologies, Inc.
Orthopedic · 50d
Cleared Jul 09, 1991
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
K912357 · KRX
R&D Systems, Inc.
Hematology · 42d
Cleared Jul 08, 1991
AIM TIBIAL NAIL
K911554 · HSB
Ace Medical Co.
Orthopedic · 90d
Cleared Jul 08, 1991
FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS
K911907 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 69d
Cleared Jul 08, 1991
PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT
K912231 · JHW
Intl. Immunoassay Laboratories, Inc.
Chemistry · 49d
Cleared Jul 08, 1991
AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM
K912651 · FYD
Stackhouse Assoc.
General Hospital · 21d
Cleared Jul 05, 1991
BUD DENTAL IMPLANT SYSTEM
K902331 · DZE
Bud Industries, Inc.
Dental · 407d
Cleared Jul 05, 1991
ACETATE-FREE DIALYSLATE SOLUTION
K903835 · KPO
Physio, Inc.
Gastroenterology & Urology · 318d
Cleared Jul 05, 1991
EASY EYES TM CONTACT LENS CLEANING MACHINE
K904824 · LYL
Eaton Medical Corp.
Ophthalmic · 253d
Cleared Jul 05, 1991
SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA
K910985 · GCJ
Precision Laser Products, Inc.
General & Plastic Surgery · 121d
Cleared Jul 05, 1991
PICC-FIX
K911070 · KMK
Sorex Medical
General Hospital · 116d
Cleared Jul 05, 1991
PAL (PROBE FOR ASPIRATION AND LAVAGE)
K911149 · GCJ
Marlo Surgical Technology
General & Plastic Surgery · 112d
Cleared Jul 05, 1991
REICH SUCTION/IRRIGATION CANNULA
K911164 · GCJ
Marlo Surgical Technology
General & Plastic Surgery · 112d