Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
154585–154608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 1984
SYSMEX CC-780 EIGHT PARAMETER AUT0
K834021
Toa Medical Electronics USA, Inc.
Hematology · 101d
Cleared Mar 02, 1984
ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS
K834242 · LJP
Apple Diagnostic Products
Immunology · 87d
Cleared Mar 02, 1984
DAT TEST FOR CHAGAS' DISEASE
K834328 · GNE
Sero-Immuno Diagnostics, Inc.
Immunology · 84d
Cleared Mar 02, 1984
ALDOSTERONE RADIOIMMUNOASSAY TEST KIT
K834428 · CJM
Serono Laboratories, Inc.
Chemistry · 78d
Cleared Mar 02, 1984
LIQUID STABLE TRIGLYCERIDES REAGENT SET
K834518 · CDT
Medical Analysis Systems, Inc.
Chemistry · 72d
Cleared Mar 02, 1984
DISCS
K840028 · JTO
Anaerobe Systems
Microbiology · 57d
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