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
167641–167664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 1979
VOLU-SOL NMB RETICULOCYTE STAIN
K792496 · KQC
Volu Sol Medical Industries
Hematology · 27d
Cleared Dec 31, 1979
SANDARE CYANMETHEMOGLOBIN REAGENT
K792503 · KHG
Sandare Chemical Co., Inc.
Hematology · 27d
Cleared Dec 31, 1979
HELENA FACTOR V DEFICIENT SUBSTRATE
K792507 · GGP
Helena Laboratories
Hematology · 27d
Cleared Dec 31, 1979
HELENA FACTOR X DEFICIENT SUBSTRATE
K792508 · GGP
Helena Laboratories
Hematology · 27d
Cleared Dec 31, 1979
HELENA FACTOR VII DEFICIENT SUB. PLASMA
K792511 · GGP
Helena Laboratories
Hematology · 26d
Cleared Dec 31, 1979
VOGEL-JOHNSON AGAR
K792542 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 21d
Cleared Dec 31, 1979
PATIENT TROLLEY B49
K792570 · FPO
Ets Rene Marzet
General Hospital · 18d
Cleared Dec 31, 1979
ALARM USED W/MONITORING SPIROMETER
K792573 · BZK
Empire Plastics Manufacturer
Anesthesiology · 18d
Cleared Dec 31, 1979
ACA ETHOSURIMIDE TEST PACK
K792584 · DLF
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 17d
Cleared Dec 31, 1979
HALO SUPPORT JACKET & ASSOC. HARDWARE
K792586 · HAX
Depuy, Inc.
Neurology · 14d
Cleared Dec 31, 1979
PHENYLETHANOL AGAR
K792593 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Dec 31, 1979
TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE.
K792594 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Dec 31, 1979
SF MEDIUM (SF BROTH, STREPTOCOCCUS
K792595 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Dec 31, 1979
TRYPTIC SOY AGAR W/PHENYLETHANOL &
K792596 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Dec 31, 1979
LIFELIFT MODELS ONE AND TWO
K792601 · FSA
Corda Int'L Holiday, Inc.
General Hospital · 13d
Cleared Dec 31, 1979
LIFELINE TLE ENDOCARDIAL PACING LEAD,
K792604 · DTB
Intermedics, Inc.
Cardiovascular · 13d
Cleared Dec 31, 1979
H-H SHUNT INTRODUCER
K792639 · GYK
Holter-Hausner Intl.
Neurology · 11d
Cleared Dec 28, 1979
PSORALITE MARK I
K791977 · KGL
Paul B. Elder Co.
General & Plastic Surgery · 87d
Cleared Dec 28, 1979
PIASMA SAFE
K792185 · KSR
Cry-O-Safe, Inc.
Hematology · 58d
Cleared Dec 27, 1979
MODEL 674 PACER ANALYZER
K792074 · DTC
Del Mar Avionics
Cardiovascular · 73d
Cleared Dec 27, 1979
MODEL 448 PACERCORDER
K792076 · DSH
Del Mar Avionics
Cardiovascular · 73d
Cleared Dec 27, 1979
MODEL 449 ELECTROCARDIOCORDER
K792078 · DSH
Del Mar Avionics
Cardiovascular · 73d
Cleared Dec 27, 1979
MODEL 447 ELECTROCARDIOCORDER
K792079 · DSH
Del Mar Avionics
Cardiovascular · 73d
Cleared Dec 27, 1979
DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO
K792272 · GEC
Dexide, Inc.
General & Plastic Surgery · 44d