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
125377–125400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 1990
OPUS TSH TEST SYSTEM
K902333 · JLW
Pb Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Jul 05, 1990
SUNSHADES, ACRYLIC LENSES, ORDER #SG-01
K902385 · HQY
Tel-Time Products
Ophthalmic · 36d
Cleared Jul 03, 1990
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823 · GWM
Abbott Laboratories
Neurology · 592d
Cleared Jul 03, 1990
CARDIAC OUTPUT COMPUTER, MODEL COM-3
K896930 · DXG
Baxter Healthcare Corp
Cardiovascular · 204d
Cleared Jul 03, 1990
ACUSON V328 AND C5432 TRANSDUCERS
K897151 · JTX
Acuson Corp.
Microbiology · 189d
Cleared Jul 03, 1990
CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
K900246 · DSI
Ppg Industries, Inc.
Cardiovascular · 167d
Cleared Jul 03, 1990
PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE
K900269 · FFL
Porges Corp.
Gastroenterology & Urology · 166d
Cleared Jul 03, 1990
ORTH-EVAC TM
K900325 · CAC
Deknatel, Inc.
Anesthesiology · 161d
Cleared Jul 03, 1990
BURNS CASUALTY SHEET
K900441 · FPY
Pilgrim Medical Services
General & Plastic Surgery · 154d
Cleared Jul 03, 1990
BURNS CASUALTY SHEET BURN ROLL
K900442 · FPY
Pilgrim Medical Services
General & Plastic Surgery · 154d
Cleared Jul 03, 1990
BURNS CASUALTY SHEET LIMB WRAP
K900443 · FPY
Pilgrim Medical Services
General & Plastic Surgery · 154d
Cleared Jul 03, 1990
SEMPERMED SURGEON'S GLOVES
K900587 · KGO
Semperit Industrial Products
General Hospital · 146d
Cleared Jul 03, 1990
ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
K900771 · FRC
3M Company
General Hospital · 133d
Cleared Jul 03, 1990
MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
K901535 · DXY
Medtronic Vascular
Cardiovascular · 92d
Cleared Jul 03, 1990
GIOTTO MAMMOGRAPHY HF
K901558 · IZH
Medical Device Marketing Network, Inc.
Radiology · 91d
Cleared Jul 03, 1990
SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.
K901624 · DTZ
Shiley, Inc.
Cardiovascular · 85d
Cleared Jul 03, 1990
GNOMOS STEREOTACTIC DEVICE
K901670 · HAW
Medical Equipment Development Co., Inc.
Neurology · 84d
Cleared Jul 03, 1990
PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS
K901682 · DSY
Pioneering Technologies, Inc.
Cardiovascular · 84d
Cleared Jul 03, 1990
MODIFIED TARGET THERAPEUTICS COILS
K901721 · HCG
Target Therapeutics
Neurology · 81d
Cleared Jul 03, 1990
CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM
K901722 · LJT
Device Labs, Inc.
General Hospital · 78d
Cleared Jul 03, 1990
SONOCA II ULTRASONIC SURGICAL DEVICE
K901737 · LFL
Holl Meditronics, Inc.
General & Plastic Surgery · 77d
Cleared Jul 03, 1990
DOBBHOFF(R) RETRIEVAL FORCEPS
K901744 · KQW
Biosearch Medical Products, Inc.
Neurology · 77d
Cleared Jul 03, 1990
CHALLENGE 5000 POWERED MUSCLE STIMULATOR
K901768 · IPF
Maximum Performance Technologies,...
Physical Medicine · 76d
Cleared Jul 03, 1990
CHALLENGE 6000 POWERED MUSCLE STIMULATOR
K901769 · IPF
Maximum Performance Technologies,...
Physical Medicine · 76d