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
163921–163944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1981
MODEL 1301 BIOTAC (TM)
K810627 · GEA
Progress Mankind Technology
General & Plastic Surgery · 24d
Cleared Apr 01, 1981
INTERMEDICS CYBERLITH I BIOPOLAR CARDI
K810383 · DXY
Intermedics, Inc.
Cardiovascular · 47d
Cleared Apr 01, 1981
CYBERLITH I PULSE GENERATOR MODEL 253-04
K810385 · DXY
Intermedics, Inc.
Cardiovascular · 47d
Cleared Apr 01, 1981
STOCK ANTIMICROBIC SOLUTIONS
K810471 · LOP
Cathra International, Inc.
Microbiology · 37d
Cleared Apr 01, 1981
SIEMENS MODEL 146-146A EXTERNAL PULSE G
K810566 · DTE
Cynergy
Cardiovascular · 29d
Cleared Apr 01, 1981
REPLICA PLATER
K810719 · JTC
Dynatech Corp.
Hematology · 15d
Cleared Apr 01, 1981
A-GENT UREA NITROGEN
K810794 · CDQ
Abbott Laboratories
Chemistry · 9d
Cleared Apr 01, 1981
PROGESTERONE KIT
K810804 · JLS
Cambridge Nuclear Corp.
Chemistry · 8d
Cleared Mar 31, 1981
HAEMONETICS 1400 ML THERAPEUTIC BAG
K810313 · KSR
Haemonetics Corp.
Hematology · 54d
Cleared Mar 31, 1981
BOSCH STAR 66F SUPER EARLEVEL AID
K810347 · ESD
Bosch Hearing Instruments, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 31, 1981
HAEMONETICS 170 Y INFUSION SET
K810365 · FPA
Haemonetics Corp.
General Hospital · 47d
Cleared Mar 31, 1981
OESOPHAGEAL THERAPY KIT
K810392 · KNT
Keymed, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 31, 1981
CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP.
K810427 · JTN
Pfizer Pharmaceuticals
Microbiology · 41d
Cleared Mar 31, 1981
PROBE COVER
K810474 · FLL
Narco Air-Shields
General Hospital · 36d
Cleared Mar 31, 1981
MODEL EM-IR
K810528 · KZM
Myo-Tronics Research, Inc.
Dental · 33d
Cleared Mar 31, 1981
CEFOTAXIME 30 MCG. SENSITIVITY DISCS.
K810546 · JTN
Difco Laboratories, Inc.
Immunology · 32d
Cleared Mar 31, 1981
CEFOTAXIME 30 MCG. SENSI-DISC.
K810564 · JTN
Bd Becton Dickinson Vacutainer...
Toxicology · 28d
Cleared Mar 31, 1981
POWER SONIC
K810577 · ESD
Qualitone
Ear, Nose, Throat · 28d
Cleared Mar 31, 1981
DADE RH CONTROL REAGENT
K810599 · KSF
American Dade
Hematology · 25d
Cleared Mar 31, 1981
AMPULED FLAME PHOTOMETER STANDARDS
K810618 · JIS
United Diagnostics, Inc.
Radiology · 22d
Cleared Mar 31, 1981
SILICONE ELASTOMER COATED LATEX FOLEY
K810630 · KOD
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Mar 31, 1981
SERALYZER SYSTEM
K810639 · CGA
Miles Laboratories, Inc.
Chemistry · 21d
Cleared Mar 31, 1981
ORAL AIRWAYS
K810651 · CAE
First Industries, Inc.
Anesthesiology · 21d
Cleared Mar 31, 1981
TUBING CONNECTORS
K810652 · BYX
First Industries, Inc.
Anesthesiology · 21d