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
153745–153768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 1984
STRIPS
K840029 · JTO
Anaerobe Systems
Microbiology · 57d
Cleared Mar 02, 1984
REAGENTS
K840030 · JTO
Anaerobe Systems
Microbiology · 57d
Cleared Mar 02, 1984
MICROBIAL DIFFERENTIATION
K840031 · JTO
Anaerobe Systems
Microbiology · 57d
Cleared Mar 02, 1984
PHADEBACT CSF POSITIVE CONTROLS
K840048 · GTY
Pharmacia, Inc.
Immunology · 56d
Cleared Mar 02, 1984
B-STREP-TECT-II
K840160 · JSI
Uti-Tect, Inc.
Microbiology · 49d
Cleared Mar 02, 1984
CELL-DYN 100 WHOLE BLOOD PLATELET
K840170 · GKL
Abbott Diagnostics
Hematology · 43d
Cleared Mar 02, 1984
EPIDURAL CATHETER TRAY
K840201 · MJL
Aries Medical, Inc.
Microbiology · 43d
Cleared Mar 02, 1984
FIBRI-PREST AUTOMATE HA34
K840211 · KQJ
Wellcome Diagnostics
Hematology · 43d
Cleared Mar 02, 1984
DRAGER BAROMED
K840279 · CAP
Draeger Medical, Inc.
Anesthesiology · 39d
Cleared Mar 02, 1984
MEDISHIELD PVM RESPIROMETER
K840453 · BZK
Ohio Medical Products
Anesthesiology · 30d
Cleared Mar 02, 1984
NOVOBIOCIN DISC
K840483 · JTO
Remel Co.
Microbiology · 25d
Cleared Mar 02, 1984
SABOURAUD AGAR SLANTS
K840518 · JSG
Scientific Device Laboratory, Inc.
Microbiology · 25d
Cleared Mar 02, 1984
LIQUID OXYGEN SYSTEM
K840534 · BYJ
The John Bunn Co.
Anesthesiology · 23d
Cleared Mar 02, 1984
SPOTTEST ACRIDINE ORANGE STAIN
K840584 · JTO
Difco Laboratories, Inc.
Microbiology · 23d
Cleared Feb 28, 1984
INFUSION PUMP
K832470 · FRN
Delta Medical Industries
General Hospital · 217d
Cleared Feb 28, 1984
MEDI-JECT
K832847 · KZH
Jack H. Ritterskamp
General Hospital · 190d
Cleared Feb 28, 1984
CALIBRE-TENTATIVE TRADENAME
K833225 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 181d
Cleared Feb 28, 1984
FILTECH TECHNETIUM-99MM RADIOPHARMACEU
K833686
Summa Medical Corp.
Cardiovascular · 120d
Cleared Feb 28, 1984
CENTRAL VEIN CATHERIZATION TRAY CC-20
K834073 · FOZ
Packaging Technologies, Inc.
General Hospital · 95d
Cleared Feb 28, 1984
LABIAL CUSPID TUBE
K834392 · DZD
Alexotek Co.
Dental · 76d
Cleared Feb 28, 1984
DISPOSABLE ICP KIT DIFF. SIZES
K840003 · GWM
Codman & Shurtleff, Inc.
Neurology · 55d
Cleared Feb 27, 1984
HEMOCCULT-C
K832311 · KHE
Menley & James Laboratories
Chemistry · 228d
Cleared Feb 27, 1984
UNIVERSAL LINE-A-PLATE
K833056 · EBO
Laurentian Laboratories
Dental · 173d
Cleared Feb 27, 1984
UNIVERSAL FIX-A-PLATE
K833057 · EBO
Laurentian Laboratories
Dental · 173d