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
87697–87720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1998
STRATUS CS TROPONIN I CALIBRATOR
K983722 · JIT
Dade Behring, Inc.
Chemistry · 14d
Cleared Nov 04, 1998
AUTOVENT 1500
K983857 · BTL
O-Two Systems Intl., Inc.
Anesthesiology · 2d
Cleared Nov 03, 1998
DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
K981378 · DRT
Datex-Engstrom, Inc.
Cardiovascular · 201d
Cleared Nov 03, 1998
2.5 MM LACTOSORB SCREWS
K981666 · DZL
Biomet, Inc.
Dental · 176d
Cleared Nov 03, 1998
SILICONE SOFT RELINE
K981691 · EBI
Harry J. Bosworth Co.
Dental · 174d
Cleared Nov 03, 1998
HALOLITE AAD SYSTEM
K981772 · CAF
Medic-Aid , Ltd.
Anesthesiology · 168d
Cleared Nov 03, 1998
HAWK ANAESTHESIA INDUCTION UNIT
K981845 · BSZ
Medical Industrial Equipment
Anesthesiology · 161d
Cleared Nov 03, 1998
VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K981886 · JAQ
Cook, Inc.
Radiology · 158d
Cleared Nov 03, 1998
SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500
K981950 · GKL
Sysmex Corp.
Hematology · 153d
Cleared Nov 03, 1998
PIPER IPPB MODEL 2055
K982016 · NHJ
Vortran Medical Technology 1, Inc.
Anesthesiology · 148d
Cleared Nov 03, 1998
BIPAP VISION VENTILATORY SUPPORT
K982454 · MNT
Respironics, Inc.
Anesthesiology · 111d
Cleared Nov 03, 1998
BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224
K982748 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 89d
Cleared Nov 03, 1998
MITRA IMAGING INC. EXHIBIT
K982769 · LLZ
Mitra Imaging, Inc.
Radiology · 88d
Cleared Nov 03, 1998
QUICKSET LIQUID AND POWDER
K982773 · EMA
Specialites Septodont
Dental · 88d
Cleared Nov 03, 1998
BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION
K982775 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 88d
Cleared Nov 03, 1998
EPIFILM OTOLOGIC LAMINA
K982870 · KHJ
Xomed, Inc.
Ear, Nose, Throat · 81d
Cleared Nov 03, 1998
EARSCAN 3
K982878 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 81d
Cleared Nov 03, 1998
MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA
K982921 · MOS
Medrad, Inc.
Radiology · 76d
Cleared Nov 03, 1998
MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC
K982959 · LNH
Medrad, Inc.
Radiology · 71d
Cleared Nov 03, 1998
BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24
K983101 · MJC
C.R. Bard, Inc.
Gastroenterology & Urology · 61d
Cleared Nov 03, 1998
COAMATIC HEPARIN
K983178 · KFF
Instrumentation Laboratory CO
Hematology · 53d
Cleared Nov 03, 1998
SMALL VAGINAL/RECTAL ELECTRODE
K983206 · KPI
Empi
Gastroenterology & Urology · 50d
Cleared Nov 03, 1998
SUPER PORCELAIN ADDMATE
K983247 · EIH
Noritake Co., Inc.
Dental · 48d
Cleared Nov 03, 1998
ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152,...
K983294 · KPE
Baxter Healthcare Corp
General Hospital · 43d