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

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175,820 results
142969–142992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 1986
UMI STEERABLE TORQUE GUIDE WIRE
K863178 · DQX
Universal Medical Instrument Corp.
Cardiovascular · 32d
Cleared Sep 19, 1986
VIBROFLEX
K863197 · ISA
Stoffregen & Co., Inc.
Physical Medicine · 31d
Cleared Sep 19, 1986
MODIFIED MAHURKAR SUBCLAVIAN & FEMORAL CATHETERS
K863322 · DQY
Quinton, Inc.
Cardiovascular · 23d
Cleared Sep 19, 1986
VARIAN RMS-2000
K863358 · IYE
Varian Assoc., Inc.
Radiology · 21d
Cleared Sep 19, 1986
SEA-BOND
K863375 · KXX
Combe, Inc.
Dental · 16d
Cleared Sep 19, 1986
SIEMENS SIRONA(R) DENTAL CHAIR
K863484 · KLC
Pelton & Crane Co.
Dental · 10d
Cleared Sep 19, 1986
PHYSI. & NURSES BRAND INSTANT KOLD & HOT KOMPRESS
K863507 · IMD
Physician & Nurses Mfg. Corp.
Physical Medicine · 10d
Cleared Sep 19, 1986
CAL (CELLOBIOSE-ARGININE-LYSINE) AGAR
K863519 · JSI
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Sep 19, 1986
MODIFIED SELF-CURE BONDING AGENT
K863522 · KLE
Dentsply Intl.
Dental · 9d
Cleared Sep 19, 1986
TOC (TWEEN 80 - OXGALL-CAFFEIC ACID) AGAR
K863523 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Sep 19, 1986
REGAN-LOWE CHARCOAL AGAR
K863524 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Sep 19, 1986
DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS
K863525 · JSI
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Sep 19, 1986
YEP (YEAST EXTRACT PHOSPHATE) AGAR
K863526 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Sep 19, 1986
CARY-BLAIR TRANSPORT MEDIUM
K863527 · JSM
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Sep 19, 1986
ROTARY MICROTOME
K863548 · IDO
Surgipath Medical Industries, Inc.
Pathology · 7d
Cleared Sep 18, 1986
MICROALBUMINURIA ASSAY
K862671 · DCF
Orion Corp.
Immunology · 66d
Cleared Sep 18, 1986
EMERSON MODEL 3HV COMPACT VENTILATOR
K862712 · CBK
J. H. Emerson Co.
Anesthesiology · 64d
Cleared Sep 18, 1986
POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER
K863035 · GXY
Valleylab, Inc.
Neurology · 38d
Cleared Sep 18, 1986
BYRON SILICONE CHIN IMPLANTS
K863397 · FWP
Byron Medical
General & Plastic Surgery · 15d
Cleared Sep 18, 1986
OXYGEN CANNULA EAR WRAP (STYLE A)
K863431 · CAT
Salter Labs
Anesthesiology · 14d
Cleared Sep 18, 1986
OXYGEN CANNULA EAR WRAP (STYLE B)
K863432 · CAT
Salter Labs
Anesthesiology · 14d
Cleared Sep 18, 1986
URESIL CLOSED DRAINAGE RESERVOIR
K863505 · GCY
Uresil Corp.
General & Plastic Surgery · 9d
Cleared Sep 18, 1986
CPU GRAPH
K863546 · CBK
Ohmeda Medical
Anesthesiology · 6d
Cleared Sep 17, 1986
40-HZ AUDITORY EVOKED RESPONSE TEST
K862361 · GWJ
Cadwell Laboratories, Inc.
Neurology · 86d