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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
136993–137016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 1988
VAN-TEC BLADDER EVACUATOR
K880099 · KQT
Van-Tec, Inc.
Gastroenterology & Urology · 50d
Cleared Mar 02, 1988
CODMAN SURGICAL PATTIE
K880402 · HBA
Codman & Shurtleff, Inc.
Neurology · 33d
Cleared Mar 02, 1988
DISPOSABLE DENTAL PROBE/EXPLORER
K880590 · EKJ
Baxter Healthcare Corp
Dental · 20d
Cleared Mar 01, 1988
KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM
K870816 · DSI
Kontron Instruments, Inc.
Cardiovascular · 364d
Cleared Mar 01, 1988
COMBISON(R) 310A REAL TIME ULTRASOUND SCANNER
K873159 · IYO
Cone Instruments, Inc.
Radiology · 203d
Cleared Mar 01, 1988
GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE
K874620 · LSL
Gen-Probe, Inc.
Microbiology · 113d
Cleared Mar 01, 1988
ADAP-TEMP, MODEL: AT-100
K874694 · FLL
Respiratory Support Products, Inc.
General Hospital · 109d
Cleared Mar 01, 1988
VIROGEN CMV ANTIBODY TEST
K875101 · LQO
Wampole Laboratories
Microbiology · 82d
Cleared Mar 01, 1988
(SKD) CHOLESTEROL TEST KIT
K875131 · CHH
Smithkline Diagnostics, Inc.
Chemistry · 77d
Cleared Mar 01, 1988
CAVIT-W
K875133 · EBG
Espe GmbH (Us)
Dental · 77d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX BARBITURATES
K880012 · DIS
Abbott Laboratories
Toxicology · 57d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA.
K880013 · DKZ
Abbott Laboratories
Toxicology · 57d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX CANNABINOIDS
K880015 · LDJ
Abbott Laboratories
Toxicology · 57d
Cleared Mar 01, 1988
DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL
K880175 · JJY
Baxter Healthcare Corp
Chemistry · 46d
Cleared Mar 01, 1988
SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM
K880188 · JDB
Howmedica Corp.
Orthopedic · 46d
Cleared Mar 01, 1988
BINAX PROLACTIN IRMA DIAGNOSTIC KIT
K880218 · CFT
Binax, Inc.
Chemistry · 41d
Cleared Mar 01, 1988
MSI-DIFF PLUS
K880270 · JPK
Medical Specialties, Inc.
Hematology · 40d
Cleared Mar 01, 1988
ALT (SGPT) REAGENT SET
K880275 · CKA
Tech-Neal Scientific, Inc.
Chemistry · 40d
Cleared Mar 01, 1988
WAKO(TM) AUTOKIT CHOLESTEROL
K880311 · CHH
Wako Chemicals USA, Inc.
Chemistry · 36d
Cleared Mar 01, 1988
IQ ALKALINE PHOSPHATASE
K880344 · CJK
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Mar 01, 1988
MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT
K880665 · GTZ
Allelix Diagnostics, Inc.
Microbiology · 12d
Cleared Feb 29, 1988
PHARMACLUSIVE (TM)
K872573 · NAD
Pharmacia, Inc.
General & Plastic Surgery · 245d
Cleared Feb 29, 1988
OLYMPUS ANGIOSCOPY SHEATH
K873100 · DYB
Olympus Corp.
Cardiovascular · 206d
Cleared Feb 29, 1988
PALL FIELD MEDICAL OXYGEN GENERA. & DISTRI. SYSTEM
K873526 · CAW
Pall Safety Atmospheres, Inc.
Anesthesiology · 181d