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
80737–80760 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
K002798 · JEY
Codman & Shurtleff, Inc.
Dental · 90d
Cleared Dec 06, 2000
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
K003455 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 29d
Cleared Dec 06, 2000
EECP THERAPY SYSTEM, MODEL TS3
K003469 · DRN
Vasomedical, Inc.
Cardiovascular · 28d
Cleared Dec 06, 2000
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)
K003483 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 27d
Cleared Dec 05, 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
K000582 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 287d
Cleared Dec 05, 2000
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND...
K001465 · FIB
Nipro Medical Corp.
Gastroenterology & Urology · 209d
Cleared Dec 05, 2000
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
K002105 · MLD
Siemens Medical Solutions USA, Inc.
Cardiovascular · 146d
Cleared Dec 05, 2000
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
K002128 · NDR
Diagnostic Systems Laboratories, Inc.
Chemistry · 144d
Cleared Dec 05, 2000
ACAPELLA
K002768 · BWF
Dhd Healthcare Corp.
Anesthesiology · 90d
Cleared Dec 05, 2000
DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM
K002775 · HRS
Hand Innovations, Inc.
Orthopedic · 90d
Cleared Dec 05, 2000
HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION
K002782 · LLZ
Nuclear Diagnostics AB
Radiology · 90d
Cleared Dec 05, 2000
FIXION INTERLOCKING NAIL (FIXION IL NAIL)
K002783 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 90d
Cleared Dec 05, 2000
MEDIPRIME
K002894 · LLZ
Algotec Systems, Ltd.
Radiology · 78d
Cleared Dec 05, 2000
JEWEL CAST III
K003037 · EJH
Jeneric/Pentron, Inc.
Dental · 67d
Cleared Dec 05, 2000
GOLD CORE II
K003039 · EJH
Jeneric/Pentron, Inc.
Dental · 67d
Cleared Dec 05, 2000
UBM PLUS, MODEL P45
K003141 · IYO
Paradigm Medical Industries, Inc.
Radiology · 56d
Cleared Dec 05, 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
K003209 · DJG
Dade Behring, Inc.
Toxicology · 53d
Cleared Dec 05, 2000
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
K003291 · JZO
Bayer Diagnostics Corp.
Immunology · 46d
Cleared Dec 05, 2000
ALBUMIN
K003327 · CIX
Jas Diagnostics, Inc.
Chemistry · 42d
Cleared Dec 05, 2000
FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
K003582 · FRN
Fluidsense Corp.
General Hospital · 15d
Cleared Dec 04, 2000
TKD SCALERS
K000846 · ELC
Orasystems
Dental · 264d
Cleared Dec 04, 2000
MODIFICATION TO INTRALASE 600C LASER KERATOME
K001211 · GEX
Intra Lase Corp.
General & Plastic Surgery · 234d
Cleared Dec 04, 2000
XPS 3000 SYSTEM
K002224 · ERL
Medtronic Xomed
Ear, Nose, Throat · 133d
Cleared Dec 04, 2000
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
K002391 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 122d