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
78793–78816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2001
N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
K003609 · NEO
Osteometer Biotech A/S
Chemistry · 175d
Cleared May 16, 2001
CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A
K003707 · MWJ
Cardionet
Cardiovascular · 166d
Cleared May 16, 2001
MODIFICATION TO MALE TO MALE LUER ADAPTER
K003712 · KOC
Molded Products, Inc.
Gastroenterology & Urology · 166d
Cleared May 16, 2001
BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
K003732 · DXN
Braun GmbH
Cardiovascular · 163d
Cleared May 16, 2001
CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F),...
K003880 · DQY
Concentric Medical, Inc.
Cardiovascular · 152d
Cleared May 16, 2001
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
K010448 · FBK
Horizons Intl. Corp.
Gastroenterology & Urology · 90d
Cleared May 16, 2001
TETHER ACFS
K010466 · KWQ
Theken Surgical,Llc
Orthopedic · 89d
Cleared May 16, 2001
BALLOON CANNULA, SHORT, MODEL R65-985
K010510 · HET
A & A Medical, Inc.
Obstetrics & Gynecology · 84d
Cleared May 16, 2001
ACTIVEECG
K010587 · DRT
Active Corp.
Cardiovascular · 78d
Cleared May 16, 2001
SEA-LONG MEDICAL TREATMENT HOOD
K010659 · CBF
Sea-Long Medical Systems, Inc.
Anesthesiology · 71d
Cleared May 16, 2001
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
K010730 · MOS
Usa Instruments, Inc.
Radiology · 65d
Cleared May 16, 2001
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609,...
K010747 · NFB
Western Ent.
Anesthesiology · 64d
Cleared May 16, 2001
UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN...
K010881 · LYY
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 54d
Cleared May 16, 2001
K-ASSAY HS-CRP CONTROLS
K011079 · DCK
Kamiya Biomedical Co.
Immunology · 37d
Cleared May 16, 2001
ELIPAR FREELIGHT
K011154 · EBZ
Espe Dental AG
Dental · 30d
Cleared May 16, 2001
E-Z EM PERCUPUMP 2001 CT INJECTOR
K011160 · JAK
E-Z-Em, Inc.
Radiology · 30d
Cleared May 16, 2001
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
K011182 · MNH
Depuyacromed
Orthopedic · 28d
Cleared May 16, 2001
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
K011213 · JGS
Beckman Coulter, Inc.
Chemistry · 26d
Cleared May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH...
K011217 · DQO
Abbott Laboratories
Cardiovascular · 26d
Cleared May 16, 2001
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
K011218 · JDI
Exactech, Inc.
Orthopedic · 26d
Cleared May 16, 2001
POWDER-FREE NITRILE EXAM GLOVE, BLUE
K011286 · LZA
Ningbo Yujiang Plastic & Rubber Co. ,...
General Hospital · 19d
Cleared May 16, 2001
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
K011306 · JXM
Syva Co., Dade Behring, Inc.
Toxicology · 16d
Cleared May 15, 2001
GUIDANT RETRIEVER DEVICE
K001694 · DQY
Guidant Cardiac and Vascular Surgery
Cardiovascular · 347d
Cleared May 15, 2001
RUBICON PROTHROMBIN TIME MONITORING SYSTEM
K001699 · GJS
Lifescan, Inc.
Hematology · 347d