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
158017–158040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1983
BETA FFIRM TEST
K823682 · JHJ
Organon, Inc.
Chemistry · 31d
Cleared Jan 07, 1983
BIO INTERFERENCE BLANKING MATERIAL
K823687 · JJX
American Monitor Corp.
Chemistry · 31d
Cleared Jan 07, 1983
PHOSPHORUS REAGENT SET
K823691 · CEO
Omega Medical Electronics
Chemistry · 30d
Cleared Jan 07, 1983
SPINAL NEEDLE
K823692 · BSP
Ocean Medical Products, Ltd.
Anesthesiology · 30d
Cleared Jan 07, 1983
VASCU-STATT APPROXIMATOR
K823694 · HRQ
Scanlan Intl., Inc.
General & Plastic Surgery · 30d
Cleared Jan 07, 1983
EPIDURAL CATHETER
K823702 · BSO
Rsp, Inc.
Anesthesiology · 29d
Cleared Jan 07, 1983
ESOPHAGEAL STETHOSCOPE
K823703 · BZW
Rsp, Inc.
Anesthesiology · 29d
Cleared Jan 07, 1983
ATS GRAM STAIN CONTROL SLIDE
K823704 · LJG
Alpha-Tec Systems, Inc.
Hematology · 29d
Cleared Jan 07, 1983
ATS PARASITOLOGY STAIN CONTROL SLIDE
K823705 · LJG
Alpha-Tec Systems, Inc.
Hematology · 29d
Cleared Jan 07, 1983
ATS AFB STAIN CONTROL SLIDE
K823706 · LJG
Alpha-Tec Systems, Inc.
Hematology · 29d
Cleared Jan 07, 1983
TRIGLYCERIDE REAGENT (UV)
K823709 · CDT
Gilford Diagnostics
Chemistry · 29d
Cleared Jan 07, 1983
DISPOSABLE NON-REBREATHING ANES. CIRCUIT
K823714 · CAI
Marquest Medical Products, Inc.
Anesthesiology · 28d
Cleared Jan 07, 1983
SPECTROPHOTOMETER
K823720 · JJQ
Macomb Chemical Co.
Chemistry · 28d
Cleared Jan 07, 1983
GRAM NEGATIVE BACTERIAL IDENTIF- PANELS
K823738 · JTO
Micro-Media Systems, Inc.
Microbiology · 25d
Cleared Jan 07, 1983
ADVANCE EMIT-AED PRIMEDONE ASSAY
K823741 · LFT
Syva Co.
Chemistry · 25d
Cleared Jan 07, 1983
ADVANCE EMIT-AED ETHOSUXIMIDE
K823745 · DLF
Syva Co.
Chemistry · 25d
Cleared Jan 07, 1983
LOW PRESSURE BLOM-SINGER VOICE PROSTHES
K823749 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 25d
Cleared Jan 07, 1983
STERILE, DISPOS. SPIKE PROTECTOR-5C4138
K823777 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 23d
Cleared Jan 07, 1983
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K823778 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 23d
Cleared Jan 07, 1983
ELASTIC COMPRESSION ANKLET
K823789 · FQL
Orthopaedic Resources Corp.
General Hospital · 22d
Cleared Jan 07, 1983
AZLOCILLIN 75MCG SENSI-DISC
K823800 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 21d
Cleared Jan 07, 1983
LASER PHOTOCOAGULATOR
K827819
American Laser Corp.
Radiology · 80d
Cleared Jan 06, 1983
MODEL 716 MICROMANIPULATOR
K828056
Laser Industries , Ltd.
Radiology · 31d
Cleared Jan 05, 1983
LENS
K821897 · KYG
Mortan, Inc.
Ophthalmic · 191d