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
79369–79392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2001
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · LDJ
ACON Laboratories, Inc.
Toxicology · 118d
Cleared Mar 15, 2001
IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM
K003899 · LNH
Mri Devices Corp.
Radiology · 87d
Cleared Mar 15, 2001
LASEREX INTEGRE, MODEL LP2532
K003955 · GEX
Ellex Medical Pty, Ltd.
General & Plastic Surgery · 84d
Cleared Mar 15, 2001
PANASONIC TELE-HOMECARE SYSTEM
K004050 · MWI
Matsushita Electric Industrial Co., Ltd.
Cardiovascular · 76d
Cleared Mar 15, 2001
ULTRAPAK NEHA
K010070 · MVL
Ultradent Products, Inc.
Dental · 66d
Cleared Mar 15, 2001
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
K010085 · OMB
Excel Tech. , Ltd.
Neurology · 63d
Cleared Mar 15, 2001
SURSHIELD WINGED INFUSION SET
K010103 · FPA
Terumo Medical Corp.
General Hospital · 62d
Cleared Mar 15, 2001
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
K010116 · IZH
Planmed OY
Radiology · 58d
Cleared Mar 15, 2001
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
K010351 · JEY
Inion , Ltd.
Dental · 37d
Cleared Mar 15, 2001
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
K010425 · KNF
Hdc Corp.
Obstetrics & Gynecology · 30d
Cleared Mar 15, 2001
LORENZ FIDUCAIL SCREW
K010427 · HAW
Walter Lorenz Surgical, Inc.
Neurology · 30d
Cleared Mar 15, 2001
MODIFICATION TO ACTICOAT FOAM DRESSING
K010447 · FRO
Westaim Biomedical, Inc.
General & Plastic Surgery · 30d
Cleared Mar 15, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
K010463 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 27d
Cleared Mar 15, 2001
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
K010523 · GTZ
Binax, Inc.
Microbiology · 21d
Cleared Mar 15, 2001
OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
K010591 · ODG
Olympus Optical Co., Ltd.
Radiology · 15d
Cleared Mar 15, 2001
SPIFE IFE CALIBRATOR AND CONTROL KIT
K010617 · DEW
Helena Laboratories
Immunology · 14d
Cleared Mar 15, 2001
NEMIO
K010631 · IYN
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Mar 15, 2001
GALIX GBI -3S-LP
K992706 · MLO
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 581d
Cleared Mar 14, 2001
'ALL 2000' % OXYGEN ANALYZER
K002382 · CCL
Analytical Industries, Inc.
Anesthesiology · 222d
Cleared Mar 14, 2001
O2/CO2 NASAL FILTERLINE
K010024 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 70d
Cleared Mar 14, 2001
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
K010061 · CEM
Dade Behring, Inc.
Chemistry · 65d
Cleared Mar 14, 2001
Y2000 POCKET RESCUE
K010191 · CBP
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 51d
Cleared Mar 14, 2001
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
K010352 · JEY
Inion , Ltd.
Dental · 36d
Cleared Mar 14, 2001
INNOVO
K010359 · FMF
Novo Nordisk A/S
General Hospital · 36d