FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83257–83280 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 2000
ZMR HIP SYSTEM-POROUS REVISION
K994286 · LPH
Zimmer, Inc.
Orthopedic · 81d
Cleared Mar 10, 2000
NONLINEAR TAPER LAG SCREW
K994382 · HWC
Theken Surgical
Orthopedic · 73d
Cleared Mar 10, 2000
AEQUALIS SHOULDER FRACTURE SYSTEM
K994392 · KWS
Tornier
Orthopedic · 73d
Cleared Mar 09, 2000
BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
K000544 · HJX
Labtician Ophthalmics, Inc.
Ophthalmic · 20d
Cleared Mar 09, 2000
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO...
K000566 · LTJ
Ortho-Clinical Diagnostics, Inc.
Immunology · 16d
Cleared Mar 09, 2000
ULTRASOUND SCANNER TYPE 2102
K000567 · IYO
B & K Medical A/S
Radiology · 16d
Cleared Mar 09, 2000
EMBRYON GIFT TRANSFER CATHETERS/SETS
K000656 · MQF
Rocket Medical Plc
Obstetrics & Gynecology · 10d
Cleared Mar 09, 2000
BRACHYVISION 6.0
K992762 · MUJ
Varian Assoc., Inc.
Radiology · 205d
Cleared Mar 09, 2000
PEGASYS ULTRA
K993946 · LLZ
Adac Laboratories
Radiology · 111d
Cleared Mar 09, 2000
INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000
K994270 · LLZ
Visualization Technology, Inc.
Radiology · 80d
Cleared Mar 08, 2000
VOYAGER/VIPER WHEELCHAIR
K000497 · IOR
Otto Bock Orthopedic Industry, Inc.
Physical Medicine · 22d
Cleared Mar 08, 2000
LUER ACCESS UNIVERSAL VIAL ADAPTER
K000657 · FMI
Baxter Healthcare Corp
General Hospital · 9d
Cleared Mar 08, 2000
BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE
K982558 · FOZ
Bd/Preefil
General Hospital · 595d
Cleared Mar 08, 2000
ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
K990718 · GEX
Laserscope
General & Plastic Surgery · 370d
Cleared Mar 08, 2000
SUPERGUARD SAFETY SYRINGE
K990831 · MEG
U.S. Safety Syringes Co., Inc.
General Hospital · 362d
Cleared Mar 08, 2000
OOCYTE ASPIRATION NEEDLE
K991271 · MQE
Casmed UK
Obstetrics & Gynecology · 330d
Cleared Mar 08, 2000
CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING,...
K992912 · DRF
Cardiac Pathways Corp.
Cardiovascular · 191d
Cleared Mar 08, 2000
LEMAITRE IRRIGATION CATHETER
K992933 · DXE
Vascutech, Inc.
Cardiovascular · 190d
Cleared Mar 08, 2000
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K993691 · FOZ
Arrow Intl., Inc.
General Hospital · 128d
Cleared Mar 08, 2000
LIFECORE SINGLE TOOTH ABUTMENT SYSTEM
K993894 · DZE
Lifecore Biomedical, Inc.
Dental · 113d
Cleared Mar 08, 2000
KAWASUMI LABORATORIES PHILEBOTOMY SET
K994323 · LHI
Kawasumi Laboratories Co., Ltd.
General Hospital · 77d
Cleared Mar 08, 2000
HORIZON LIGHT
K994375 · FRN
B.Braun Medical, Inc.
General Hospital · 72d
Cleared Mar 07, 2000
CAUTERY FORCEPS WITH FOOTSWITCH
K000250 · GEI
Starion Instruments
General & Plastic Surgery · 40d
Cleared Mar 07, 2000
ELECSYS CORTISOL TEST SYSTEM
K000270 · JJY
Roche Diagnostics Corp.
Chemistry · 39d