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
82057–82080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2000
COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH...
K001280 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 24d
Cleared May 15, 2000
STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI...
K001444 · JOJ
Steritec Products, Inc.
General Hospital · 7d
Cleared May 15, 2000
BVBLUE
K993732 · MXB
Gryphus Diagnostics, LLC
Chemistry · 193d
Cleared May 15, 2000
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200...
K993760 · LYY
Hartalega Sdn Bhd
General Hospital · 189d
Cleared May 15, 2000
ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX
K994334 · DYB
Daig Corp.
Cardiovascular · 144d
Cleared May 12, 2000
METRISCAN BONE DENSITY SYSTEM
K000162 · KGI
Alara, Inc.
Radiology · 114d
Cleared May 12, 2000
WALLSTENT ENTERNAL PROSTHESIS
K000281 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 102d
Cleared May 12, 2000
HYDRO2, HS-75
K000485 · HQD
Innovision, Inc.
Ophthalmic · 88d
Cleared May 12, 2000
MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM
K000630 · LLZ
Hopkins Imaging Systems, Inc.
Radiology · 78d
Cleared May 12, 2000
PHILIPS CT SECURA MV
K000819 · JAK
Philips Medical Systems North...
Radiology · 60d
Cleared May 12, 2000
URETHROTOME 8667.XXX AND 8670.XXX
K000905 · EZO
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 52d
Cleared May 12, 2000
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9,...
K000915 · MQK
Humagen Fertility Diagnostics, Inc.
Obstetrics & Gynecology · 51d
Cleared May 12, 2000
OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
K000948 · FEQ
Keymed (Medical & Industrial...
Gastroenterology & Urology · 50d
Cleared May 12, 2000
EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
K000950 · MQF
Labotect Labor-Technik Gottingen
Obstetrics & Gynecology · 50d
Cleared May 12, 2000
DELTA 16 TACT
K001171 · IZH
Instrumentarium Imaging, Inc.
Radiology · 31d
Cleared May 12, 2000
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER...
K001198 · DQX
Datascope Corp.
Cardiovascular · 29d
Cleared May 12, 2000
ESPIRT
K001208 · CBK
Respironics, Inc.
Anesthesiology · 28d
Cleared May 12, 2000
GE SYSTEM FIVE
K001267 · IYN
Ge Medical Systems, Inc.
Radiology · 22d
Cleared May 12, 2000
PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
K001368 · LHI
Carmel Pharma Ab.
General Hospital · 11d
Cleared May 12, 2000
BALLOON FOR ULTRASONIC ENDOSCOPES
K992178 · ITX
N.M. Beale Co., Inc.
Radiology · 319d
Cleared May 12, 2000
AIRPILOTMASK, MODEL TMS-900
K992192 · BZD
Tiara Medical Systems, Inc.
Anesthesiology · 318d
Cleared May 12, 2000
SPIROVIT SP-2, PNEUMOCHECK II
K992823 · BZG
Schiller AG
Anesthesiology · 263d
Cleared May 11, 2000
PQ1
K000189 · KLE
Ultradent Products, Inc.
Dental · 111d
Cleared May 11, 2000
LATERAL PIVOT INSERT
K000590 · JWH
Encore Orthopedics, Inc.
Orthopedic · 80d