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
163177–163200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1981
MUELLER-HINTON
K811608 · JTZ
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
MANNITOL SALT AGAR
K811609 · JSI
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
EOSIN METHYLENE BLUE AGAR (LEVINE)
K811610 · JSI
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
MACCONKEY AGAR
K811611 · JSI
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
TRYPTIC SOY AGAR
K811612 · JSG
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.
K811617 · DCK
Kallestad Laboratories, Inc.
Immunology · 17d
Cleared Jun 25, 1981
EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL
K811618 · DIF
Syva Co.
Toxicology · 17d
Cleared Jun 25, 1981
EMIT-ST SERUM PHENOBARBITAL CONTROLS
K811619 · LAS
Syva Co.
Toxicology · 17d
Cleared Jun 25, 1981
EMIT-TOX SERUM CALIBRATORS
K811620 · DKB
Syva Co.
Toxicology · 17d
Cleared Jun 25, 1981
EMIT-ST SERUM PHENOBARBITAL ASSAY
K811621 · DLZ
Syva Co.
Toxicology · 17d
Cleared Jun 25, 1981
EMIT-ST SERUM PHENOBARBITAL CALIBRATOR
K811622 · DLJ
Syva Co.
Toxicology · 17d
Cleared Jun 25, 1981
POWERED WHEELCHAIR
K811656 · ITI
The Oec Group
Physical Medicine · 13d
Cleared Jun 25, 1981
POTASSIUM TEST
K811661 · CEJ
King Diagnostics, Inc.
Chemistry · 10d
Cleared Jun 25, 1981
ALBUMIN TEST
K811662 · CIX
King Diagnostics, Inc.
Chemistry · 10d
Cleared Jun 25, 1981
CREATININE TEST
K811664 · CGX
King Diagnostics, Inc.
Chemistry · 10d
Cleared Jun 25, 1981
TOTAL PROTEIN TEST
K811673 · CEK
King Diagnostics, Inc.
Chemistry · 10d
Cleared Jun 25, 1981
SURGICAL INSTRUMENTS FOR USE W/ZIMMER
K811675 · HRX
Zimmer, Inc.
Orthopedic · 10d
Cleared Jun 25, 1981
CYLINDER KNEE CAST/SPLINT
K811689 · ITQ
Surgical Appliance Industries, Inc.
Physical Medicine · 10d
Cleared Jun 25, 1981
ANKLE-FOOT CAST/SPLINT
K811690 · IQI
Surgical Appliance Industries, Inc.
Physical Medicine · 10d
Cleared Jun 24, 1981
CASTLE STEAM STERILIZATION INDICATOR
K810614 · JOJ
Sybron Corp.
General Hospital · 107d
Cleared Jun 24, 1981
FORECASTER
K810832 · LHD
Forecaster Co.
Obstetrics & Gynecology · 91d
Cleared Jun 24, 1981
CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS
K810999 · KLK
Cordis Corp.
Anesthesiology · 72d
Cleared Jun 24, 1981
HUMIDIFIER W/ OR W/OUT ADAPTOR
K811161 · KFZ
Airlife, Inc.
Anesthesiology · 57d
Cleared Jun 24, 1981
EFTEKHAR CENTRALIZING PLUG
K811293 · JDI
Zimmer, Inc.
Orthopedic · 44d