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
127609–127632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1990
LATEX PATIENT EXAMINATION GLOVES
K897038 · LYY
Multi Trading Corp. of America, Inc.
General Hospital · 30d
Cleared Jan 17, 1990
LATEX PATIENT EXAMINATION GLOVES
K897047 · LYY
P.T. Gotong Rojong Djaja
General Hospital · 30d
Cleared Jan 17, 1990
DISPOSINEEDLE SHARPS DISPOSAL UNIT
K897095 · MMK
Specialites Septodont
General Hospital · 27d
Cleared Jan 16, 1990
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A
K893579 · GNX
Whittaker Bioproducts, Inc.
Microbiology · 252d
Cleared Jan 16, 1990
BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH
K894510 · HCC
Capscan Corp.
Neurology · 181d
Cleared Jan 16, 1990
RIA (CONDOM)
K895091 · HIS
La Technology Sdn. Bhd.
Obstetrics & Gynecology · 161d
Cleared Jan 16, 1990
EVER-SHARP BIOPSY FORCEPS
K895303 · HFB
Southwest Medical Mfg., Inc.
Obstetrics & Gynecology · 140d
Cleared Jan 16, 1990
MODEL 210 IMPEDANCE SYSTEM
K895443 · ETY
Virtual Corp.
Ear, Nose, Throat · 130d
Cleared Jan 16, 1990
MINI PRIMO PLUS ASP BEHIND-THE-EAR HEARING AID
K896057 · ESD
Rexton, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 16, 1990
HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A
K896216 · CBS
Hewlett-Packard Co.
Anesthesiology · 78d
Cleared Jan 16, 1990
MODEL 340 PROBE MIC SYSTEM
K896301 · ETW
Virtual Corp.
Ear, Nose, Throat · 78d
Cleared Jan 16, 1990
BASIC CALCIUM HYDROXIDE LINER
K896529 · EJK
Ivoclar North America, Inc.
Dental · 63d
Cleared Jan 16, 1990
EBV VCA ANTIBODY (IGM)
K896594 · LJN
Hillcrest Biologicals
Microbiology · 56d
Cleared Jan 12, 1990
OPTISOL
K894162 · LYX
Chiron Ophthalmics
Ophthalmic · 212d
Cleared Jan 12, 1990
ASTRA DISPOSABLE SPRAY CANNULA
K894755 · CCT
Astra Pharmaceutical Products, Inc.
Anesthesiology · 169d
Cleared Jan 12, 1990
LIFECARE NASAL MASK KIT CAT. NO. 06-800
K894779 · BYE
Lifecare Services, Inc.
Anesthesiology · 169d
Cleared Jan 12, 1990
VAC FIX(R) SYSTEM
K895697 · IYE
S&S Par Scientific
Radiology · 113d
Cleared Jan 12, 1990
DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20
K896029 · IYO
G.W.B. Intl., Ltd.
Radiology · 87d
Cleared Jan 12, 1990
AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)
K896031 · HIO
Concord/Portex
Obstetrics & Gynecology · 88d
Cleared Jan 12, 1990
MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC
K896309 · LNH
Instrumentarium Imaging, Inc.
Radiology · 72d
Cleared Jan 12, 1990
SEMPERMED LATEX EXAMINATION GLOVES
K896428 · LYY
Semperit Industrial Products
General Hospital · 65d
Cleared Jan 12, 1990
VISTA MR 2055 HP SYSTEM
K896508 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 58d
Cleared Jan 12, 1990
LIBERTY SPECIAL AND LIBERTY STAIRLIFTS
K896628 · ILK
The Cheney Co.
Physical Medicine · 52d
Cleared Jan 12, 1990
DISPOSABLE FACE MASK
K896773 · BYG
Cadema Medical Products, Inc.
Anesthesiology · 42d