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
142705–142728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1986
PORTABLE ISOKINETICS 3004 KNEE UNIT
K862996 · IKK
Kent Design & Manufacturing, Inc.
Physical Medicine · 12d
Cleared Aug 20, 1986
PORTABLE ISOKINETICS 3005 HIP UNIT
K862997 · IKK
Kent Design & Manufacturing, Inc.
Physical Medicine · 12d
Cleared Aug 20, 1986
PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT
K862998 · IKK
Kent Design & Manufacturing, Inc.
Physical Medicine · 12d
Cleared Aug 20, 1986
PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS
K863033 · BZO
Intertech/Ohio
Anesthesiology · 9d
Cleared Aug 19, 1986
PRISTINE CULTURE CATHETER
K860325 · KOD
Hall/Mccollum Laboratories, Inc.
Gastroenterology & Urology · 202d
Cleared Aug 19, 1986
SEAMED MODEL 3000
K860462 · DTC
Seamed Corp.
Cardiovascular · 194d
Cleared Aug 19, 1986
ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT
K860823 · CFT
Cis-Us, Inc.
Chemistry · 168d
Cleared Aug 19, 1986
WORLDS BEST AND WORLDS BEST EXTRA SERIES (CONDOMS)
K860909 · HIS
U. C. Import & Co.
Obstetrics & Gynecology · 162d
Cleared Aug 19, 1986
WAKO MICRO TP
K861508 · CEK
Wako Chemicals USA, Inc.
Chemistry · 118d
Cleared Aug 19, 1986
MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER
K861623 · FLL
Luxtron
General Hospital · 112d
Cleared Aug 19, 1986
SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)
K861697 · LCP
Awareness Technology, Inc.
Hematology · 106d
Cleared Aug 19, 1986
MODIFIED IDEIA CHLAMYDIA TEST
K861966 · LJC
Boots-Celltech Diagnostics, Inc.
Microbiology · 91d
Cleared Aug 19, 1986
LYPHOCHEK URINE TOXICOLOGY CONTROL
K861970 · DIF
Bio-Rad
Toxicology · 90d
Cleared Aug 19, 1986
ENZYMUN-TEST HCG
K862108 · DHA
Boehringer Mannheim Corp.
Chemistry · 77d
Cleared Aug 19, 1986
DEKNA BAND KIT
K862115 · ITG
Deknatel, Inc.
Physical Medicine · 77d
Cleared Aug 19, 1986
DAKO ITA, IMMUNOGLOBULIN A (IGA)
K862183 · CZP
Dako Corp.
Immunology · 71d
Cleared Aug 19, 1986
DAKO ITA, IMMUNOGLOBULIN M (IGM)
K862184 · DAH
Dako Corp.
Immunology · 71d
Cleared Aug 19, 1986
MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN
K862227 · HHR
Hgm, Inc.
Obstetrics & Gynecology · 69d
Cleared Aug 19, 1986
MAPLE ALLERGEN DISC
K862266 · DHB
Immuno Nuclear Corp.
Immunology · 67d
Cleared Aug 19, 1986
MODIFICATION OF TISSUE DILATOR
K862288 · DRE
Quinton, Inc.
Cardiovascular · 64d
Cleared Aug 19, 1986
KING DIAGNOSTICS LDH TEST
K862306 · CFJ
King Diagnostics, Inc.
Chemistry · 63d
Cleared Aug 19, 1986
DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM
K862320 · LJP
Difco Laboratories, Inc.
Microbiology · 62d
Cleared Aug 19, 1986
TRANS-PULSE MODEL #1103
K862355 · GZJ
The Sun Co.
Neurology · 57d
Cleared Aug 19, 1986
MODIFIED CARDIOTOMY RESERVOIR 5M1470
K862357 · DTN
3M Health Care, Sarns
Cardiovascular · 57d