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
137473–137496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1987
TITAN GEL REP LDH-30 HV
K874142 · CFE
Helena Laboratories
Chemistry · 42d
Cleared Nov 24, 1987
TITAN GEL REP LDH-6 HV
K874145 · CFE
Helena Laboratories
Chemistry · 42d
Cleared Nov 24, 1987
ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS
K874295 · BZT
Sheridan Catheter Corp.
Anesthesiology · 35d
Cleared Nov 24, 1987
EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683
K874397 · LBS
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Nov 24, 1987
CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT
K874456 · LIO
Tm & M C/O Burditt,Bowles,Radzius &...
Microbiology · 27d
Cleared Nov 24, 1987
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
K874578 · KLS
Syva Co.
Chemistry · 18d
Cleared Nov 24, 1987
ACE SELFTAPPING CANCELLOUS BONE SCREW
K874593 · HWC
Ace Medical Co.
Orthopedic · 15d
Cleared Nov 23, 1987
PROTEIN STANDARD CALIBRATOR
K871755 · JIX
Wako Chemicals USA, Inc.
Chemistry · 202d
Cleared Nov 23, 1987
VITALOG PMS-8 (MODIFICATION)
K871813 · BZQ
Vitalog Corp.
Anesthesiology · 199d
Cleared Nov 23, 1987
CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/
K871928 · HIF
Medline Industries, Inc.
Obstetrics & Gynecology · 189d
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