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
142441–142464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1986
MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY
K862423 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 82d
Cleared Sep 15, 1986
SKINTACT AG ELECTRODES
K862618 · DRX
Leon H. Lang Co.
Cardiovascular · 68d
Cleared Sep 15, 1986
LS9000 SUCTION BIOPSY NEEDLE
K862749 · GDM
Engineering, Inc.
General & Plastic Surgery · 56d
Cleared Sep 15, 1986
COMPANION 2500 PORTABLE VOLUME VENTILATOR
K862810 · CBK
Puritan Bennett Corp.
Anesthesiology · 53d
Cleared Sep 15, 1986
AKERSCAN COLORIMETRIC ANALYZER
K862908 · JJQ
Akers Medical Technologies
Chemistry · 46d
Cleared Sep 15, 1986
THERAPEUTIC DRUG MONITORING CONTROL SET
K862963 · JJY
American Monitor Corp.
Chemistry · 40d
Cleared Sep 15, 1986
ULTRASCAN CLINICAL ANALYZER
K862999 · JJQ
Specialty Medical Industries, Inc.
Chemistry · 38d
Cleared Sep 15, 1986
SERO-STAT R II STAPHYLOCOCCUS TEST
K863025 · LHT
Scott Laboratories, Inc.
Microbiology · 35d
Cleared Sep 15, 1986
ABBOTT TESTPACK (TM) HCG SERUM
K863032 · JHI
Abbott Laboratories
Chemistry · 35d
Cleared Sep 15, 1986
MEADOW FESCUE ALLERGEN DISC
K863098 · DHB
Immuno Nuclear Corp.
Immunology · 33d
Cleared Sep 15, 1986
TESTPACK ACUTE HCG SERUM CONTROLS
K863126 · JJX
Abbott Laboratories
Chemistry · 31d
Cleared Sep 15, 1986
TESTPACK ACUTE HCG URINGE CONTROLS
K863127 · JJW
Abbott Laboratories
Chemistry · 31d
Cleared Sep 15, 1986
BACTEC 13A MEDIUM (7H13)
K863191 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 27d
Cleared Sep 15, 1986
CARDS(TM) HCG-URINE
K863199 · JHI
Pacific Biotech, Inc.
Chemistry · 27d
Cleared Sep 15, 1986
NEIS NZY
K863216 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 26d
Cleared Sep 15, 1986
ALBUMIN PROCEDURE
K863263 · CIX
Data Medical Associates, Inc.
Toxicology · 21d
Cleared Sep 15, 1986
CARE + PLUS SUTURE REMOVAL TRAY
K863283
Welmed Systems, Inc.
General & Plastic Surgery · 21d
Cleared Sep 15, 1986
SUPERFIXATION(TM)
K863343 · KTT
Orthopaedic Device Corp.
Orthopedic · 17d
Cleared Sep 15, 1986
FACIAL MASSAGER, BATTERY POWERED
K863383 · ISA
General Physiotherapy, Inc.
Physical Medicine · 12d
Cleared Sep 12, 1986
CARDIAN II CR45A
K861621 · DRT
Cardiac Recorders, Ltd.
Cardiovascular · 136d
Cleared Sep 12, 1986
E-Z CLEAN
K862221 · GEI
American Medical Products, Inc.
General & Plastic Surgery · 93d
Cleared Sep 12, 1986
EZ LOAD MODEL 30, ALL LEVEL COT
K862441 · FPO
Ferno-Washington, Inc.
General Hospital · 78d
Cleared Sep 12, 1986
WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER
K862471 · LRA
Institute of Logopedics
Ear, Nose, Throat · 74d
Cleared Sep 12, 1986
QUARTZ RODS TITANIUM RODS
K862472 · GEX
Quali-Med, Inc.
General & Plastic Surgery · 74d