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
142369–142392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 1986
STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR
K863500 · EIS
Pacific Union Dental, Inc.
Dental · 13d
Cleared Sep 19, 1986
MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD
K862053 · DTB
Intermedics, Inc.
Cardiovascular · 113d
Cleared Sep 19, 1986
MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD
K862054 · DTB
Intermedics, Inc.
Cardiovascular · 113d
Cleared Sep 19, 1986
COLOR FLOW MAPPING (CFM) OPTION - MODEL 77020 CF
K862151 · IYO
Hewlett-Packard Co.
Radiology · 107d
Cleared Sep 19, 1986
NOZEES NOSTRIL DILATOR
K862406 · LWF
Nozees Co.
Ear, Nose, Throat · 86d
Cleared Sep 19, 1986
PANAGRAF
K862829 · KLE
Panadent International, Inc.
Dental · 56d
Cleared Sep 19, 1986
MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY
K862862 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 52d
Cleared Sep 19, 1986
APNET RESPIRATION MONITOR
K862962 · BZQ
Wireless Monitors, Inc.
Anesthesiology · 44d
Cleared Sep 19, 1986
ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES
K862983 · DQX
Target Therapeutics
Cardiovascular · 43d
Cleared Sep 19, 1986
DENTAL COMPOSITE RESTORATIVE
K863092 · EBF
Dentsply Intl.
Dental · 37d
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