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
88201–88224 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
K983209 · DKB
Beckman Coulter, Inc.
Toxicology · 51d
Cleared Nov 04, 1998
IGG
K983221 · DEW
Abbott Laboratories
Immunology · 51d
Cleared Nov 04, 1998
ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS
K983285 · EIA
Engle Dental Systems
Dental · 47d
Cleared Nov 04, 1998
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
K983304 · CIG
Synermed Intl., Inc.
Chemistry · 44d
Cleared Nov 04, 1998
C4
K983356 · DBI
Abbott Laboratories
Immunology · 41d
Cleared Nov 04, 1998
IGA
K983359 · CZP
Abbott Laboratories
Immunology · 41d
Cleared Nov 04, 1998
C3
K983441 · CZW
Abbott Laboratories
Immunology · 35d
Cleared Nov 04, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY
K983507 · JJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared Nov 04, 1998
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
K983693 · JIT
Dade Behring, Inc.
Chemistry · 14d
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