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
103321–103344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1995
OXYLATOR EM-100
K944349 · BTL
Cpr Medical Devices, Inc.
Anesthesiology · 223d
Cleared Apr 17, 1995
SCIMED(R) COURIER GUIDE CATHETER
K946272 · DQY
Scimed Peripheral Interventions
Cardiovascular · 115d
Cleared Apr 17, 1995
ULTRACELL ORTHOPEDIC SPONGES
K950370 · GDY
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Apr 17, 1995
ULTRACELL ORTHOPEDIC SPONGES
K950372 · GDY
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Apr 17, 1995
ULTRACELL ORTHOPEDIC SPONGES
K950373 · GDY
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Apr 17, 1995
LOCKETT MEDICAL CORP. GAUZE
K950404 · EFQ
Lockett Medical Corp.
General & Plastic Surgery · 76d
Cleared Apr 17, 1995
N/T PROTEIN CONTROL PY
K951012 · GIL
Behring Diagnostics, Inc.
Hematology · 42d
Cleared Apr 17, 1995
OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT
K951013 · CFQ
Olympus America, Inc.
Immunology · 42d
Cleared Apr 17, 1995
SPECULUM, ENT (S3)
K951049 · ERA
Pedia Pals, Inc.
Ear, Nose, Throat · 42d
Cleared Apr 17, 1995
SPECULUM, ENT (S3)
K951050 · ERA
Pedia Pals, Inc.
Ear, Nose, Throat · 42d
Cleared Apr 17, 1995
OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT
K951055 · CFQ
Olympus America, Inc.
Immunology · 41d
Cleared Apr 17, 1995
VARELISA ANA-4 SCREEN
K951186 · LJM
Elias U.S.A., Inc.
Immunology · 32d
Cleared Apr 17, 1995
VARELISA ANA PROFILE
K951205 · LJM
Elias U.S.A., Inc.
Immunology · 31d
Cleared Apr 17, 1995
VARELISA PARIETAL CELL ANTIBODIES
K951206 · MLE
Elias U.S.A., Inc.
Immunology · 31d
Cleared Apr 17, 1995
VARELISA HISTONE ANTIBODIES
K951207 · LJM
Elias U.S.A., Inc.
Immunology · 31d
Cleared Apr 17, 1995
INTRAARC DRIVE SYSTEM
K951263 · ERL
Linvatec Corp.
Ear, Nose, Throat · 27d
Cleared Apr 17, 1995
RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS)
K951560 · IOR
Radius Intl., Inc.
Physical Medicine · 12d
Cleared Apr 14, 1995
CO2 INSUFFLATOR 1100
K930013 · HIF
Hi Tec Medical Vertriebs-GmbH Fur...
Obstetrics & Gynecology · 830d
Cleared Apr 14, 1995
NITE-GUIDE
K931615 · KMY
Ortho-Tain, Inc.
Dental · 743d
Cleared Apr 14, 1995
CARD GUARD
K934795 · BZH
Card Guard Scientific Survival , Ltd.
Anesthesiology · 555d
Cleared Apr 14, 1995
DRIED GRAM-NEGATIVE MIC//COMBO PANELS
K935704 · LTT
Baxter Diagnostics, Inc.
Microbiology · 500d
Cleared Apr 14, 1995
GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300
K940009 · DRG
General Devices
Cardiovascular · 465d
Cleared Apr 14, 1995
VARIANT TOTAL GHB PROGRAM
K941616 · LCP
Bio-Rad
Hematology · 375d
Cleared Apr 14, 1995
ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS
K941709 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 373d