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
138073–138096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1987
VISION CARE/PHAKOSYSTEMS ECHORULE
K871938 · IYO
Phakosystems, Inc.
Radiology · 189d
Cleared Nov 23, 1987
MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPH
K871993 · DPS
Cambridge Medical Instruments, Inc.
Cardiovascular · 181d
Cleared Nov 23, 1987
REFLOTRON BILIRUBIN
K872818 · CIG
Boehringer Mannheim Corp.
Chemistry · 130d
Cleared Nov 23, 1987
STAND AID
K872934 · IPL
Stand Aid of Iowa, Inc.
Physical Medicine · 119d
Cleared Nov 23, 1987
THER-A-PULSE
K872970 · IPF
Westec Corp.
Physical Medicine · 116d
Cleared Nov 23, 1987
DYNATRAC
K872974 · IPF
Med*Ex Diagnostics of Canada, Inc.
Physical Medicine · 116d
Cleared Nov 23, 1987
COLOR FLOW IMAGING
K873096 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 108d
Cleared Nov 23, 1987
TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS
K873183 · DIF
Abbott Laboratories
Toxicology · 103d
Cleared Nov 23, 1987
ZOLL NTP-1200 PACER/DEFIBRILLATOR
K873402 · DRO
Zmi Corp.
Cardiovascular · 91d
Cleared Nov 23, 1987
ECG ELECTRODE SYSTEM
K873442 · DRX
Hiltrode, Inc.(A/S) Subsidiary...
Cardiovascular · 88d
Cleared Nov 23, 1987
PARAMAX PHOSPHORUS REAGENT
K873454 · CEO
Baxter Healthcare Corp
Chemistry · 87d
Cleared Nov 23, 1987
PARAMAX URIC ACID REAGENT
K873456 · KNK
Baxter Healthcare Corp
Chemistry · 87d
Cleared Nov 23, 1987
VAN DELLEN ASPIRATING TUBING
K873463 · BYY
Van Dellen, Ltd.
General Hospital · 87d
Cleared Nov 23, 1987
VAN DELLEN CANNULA
K873464 · JOL
Van Dellen, Ltd.
General Hospital · 87d
Cleared Nov 23, 1987
PARAMAX AMYLASE REAGENT
K873520 · CJA
Baxter Healthcare Corp
Chemistry · 83d
Cleared Nov 23, 1987
PARAMAX CREATININE REAGENT
K873531 · CGX
Baxter Healthcare Corp
Chemistry · 83d
Cleared Nov 23, 1987
PARAMAX UREA NITROGEN REAGENT
K873532 · CDQ
Baxter Healthcare Corp
Chemistry · 83d
Cleared Nov 23, 1987
OVUGEN SURETEST
K873534 · CEP
Biogenex Laboratories
Chemistry · 83d
Cleared Nov 23, 1987
APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY
K873563 · JOL
Aplicare, Inc.
General Hospital · 82d
Cleared Nov 23, 1987
IMSI, VITAL CALL
K873612 · IQA
Intl. Management Services, Inc.
Physical Medicine · 76d
Cleared Nov 23, 1987
MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM
K873680 · DSI
Oxford Medilog, Inc.
Cardiovascular · 70d
Cleared Nov 23, 1987
CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504
K873788 · JHI
Pacific Biotech, Inc.
Chemistry · 67d
Cleared Nov 23, 1987
MODEL 500E INFANT MONITORING SYSTEM
K873791 · BZQ
Ge Medical Systems Information...
Anesthesiology · 67d
Cleared Nov 23, 1987
REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801
K873832 · KRZ
In Vitro Diagnostics, Inc.
Hematology · 63d