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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
170617–170640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1978
CARDIOPNEUMOGRAPH
K781292 · DRT
Street Electronics Corp.
Cardiovascular · 57d
Cleared Sep 20, 1978
T.E.D. SEQUENTIAL COMPRESSION SLEEVES
K781357 · JOW
Kendall Research Center
Cardiovascular · 43d
Cleared Sep 20, 1978
SEQUENTIAL CUFF INFLATION DEVICE
K781358 · JOW
Medasonics, Inc.
Cardiovascular · 43d
Cleared Sep 20, 1978
MS-2 AUTOMATED URINE SCREENING SYSTEM
K781370 · JXA
Abbott Laboratories
Microbiology · 43d
Cleared Sep 20, 1978
BONE MARROW ASPIRATION KIT
K781371 · GAA
Ferris Mfg. Corp.
General & Plastic Surgery · 43d
Cleared Sep 20, 1978
OSTOMY APPLIANCE W/DEODORIZING FILTER
K781373 · EXB
Hollister, Inc.
Gastroenterology & Urology · 44d
Cleared Sep 20, 1978
COMFORM ABSORBANT INCONTINENCE PADS
K781375 · EYQ
Kimberly-Clark Corp.
Gastroenterology & Urology · 42d
Cleared Sep 20, 1978
INSTA-PULSE HEART RATE MONITOR
K781387 · DRT
Bio Sig Instruments, Inc.
Cardiovascular · 41d
Cleared Sep 20, 1978
TECA MODEL B9 ELECTROMYOGRAPH
K781399 · IKN
Teca, Inc.
Neurology · 36d
Cleared Sep 20, 1978
HEMOVAC TUBING MATERIAL CHANGE
K781400 · GCY
Snyder Laboratories, Inc.
General & Plastic Surgery · 36d
Cleared Sep 20, 1978
CORNEAL CUTTER AND ACCESSORIES
K781411 · HRH
Codman & Shurtleff, Inc.
Ophthalmic · 36d
Cleared Sep 20, 1978
PRECISION GAS MIXER
K781417 · LCH
Medicor USA , Ltd.
Chemistry · 35d
Cleared Sep 20, 1978
BIOSCAN E12
K781421 · JJS
Clinifax Industries, Ltd.
Chemistry · 34d
Cleared Sep 20, 1978
LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA
K781454 · CHW
Union Carbide Corp.
Chemistry · 29d
Cleared Sep 20, 1978
FOLEY CATHETERS
K781457 · KOD
Intermed, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 20, 1978
MICROSURGICAL KNIVES, 20, 30, 45
K781465 · HNN
Codman & Shurtleff, Inc.
Ophthalmic · 26d
Cleared Sep 20, 1978
TILLMAN HIPSURFACE REPLACEMENT
K781490 · KXA
Waldemar Link GmbH & Co. KG
Orthopedic · 23d
Cleared Sep 20, 1978
SILASTIC U-TUBE KIT
K781526 · GBO
Dow Corning Corp. Healthcare...
General & Plastic Surgery · 15d
Cleared Sep 15, 1978
CEA-IMMERSIBLE SEPARATOR
K781043 · JRL
Millipore Corp.
Immunology · 87d
Cleared Sep 15, 1978
STEMPLEX
K781167 · IPF
Rich-Mar Corp.
Physical Medicine · 64d
Cleared Sep 15, 1978
SIGNAL AVERAGER MODEL 4202
K781290 · GWK
Princeton Applied Research Corp.
Neurology · 50d
Cleared Sep 15, 1978
AC ADAPTER:MODELS 9525,9526,9527
K781535 · DXG
Edwards Laboratories
Cardiovascular · 9d
Cleared Sep 14, 1978
OXYGENATOR, BUBBLE TYPE
K780078 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 240d
Cleared Sep 14, 1978
PRESSURE INFUSION DEVICE
K781037 · KZD
Hinck Medical, Inc.
General Hospital · 87d