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
143641–143664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1986
SURGICAL KNIFE
K861947 · EMF
Sharpoint, Inc.
General & Plastic Surgery · 17d
Cleared Jun 06, 1986
COMPOUND LEVERAGE SNIP
K861952
Med-Tool, Inc.
General & Plastic Surgery · 17d
Cleared Jun 06, 1986
PARALLEL ACTION PLIERS
K861953 · HTC
Med-Tool, Inc.
General & Plastic Surgery · 17d
Cleared Jun 06, 1986
HEXAGONAL WRENCHES
K861954
Med-Tool, Inc.
General & Plastic Surgery · 17d
Cleared Jun 05, 1986
POLO DENTAL UNIT
K854647 · KLC
Alpine Dental Equipment Co.
Dental · 198d
Cleared Jun 05, 1986
4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH
K854665 · OLV
Nihon Kohden America, Inc.
Neurology · 197d
Cleared Jun 05, 1986
LNI MGV MEDICAL GAS MIXER
K854769 · BZR
P.A. Mccauley, Inc.
Anesthesiology · 190d
Cleared Jun 05, 1986
MODEL 8604 OXYGEN/PULSE MONITOR
K860051 · DQA
Nonin Medical, Inc.
Anesthesiology · 150d
Cleared Jun 05, 1986
2500 PRINTER
K860164
Datascope Corp.
Cardiovascular · 139d
Cleared Jun 05, 1986
LASER RESISTANT TRACHEAL TUBE (TENTATIVE)
K860901 · BTR
Mallinckrodt Critical Care
Anesthesiology · 87d
Cleared Jun 05, 1986
TM-3600 A NEURODIAGNOSTIC SYSTEM
K860903 · GWF
Tracor Northern, Inc.
Neurology · 87d
Cleared Jun 05, 1986
PARAGON 420, CARDIAC MONITOR
K861067 · DPS
Life Sensing Instrument Company, Inc.
Cardiovascular · 77d
Cleared Jun 05, 1986
COLLINS PNEUMOTACH PFT SYSTEM
K861227 · BZG
Warren E. Collins, Inc.
Anesthesiology · 65d
Cleared Jun 05, 1986
RX-33S INTRA MINI CANAL MODULE
K861532 · ESD
Rexton, Inc.
Ear, Nose, Throat · 42d
Cleared Jun 05, 1986
CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT
K861555 · BZD
Respiratory Care, Inc.
Anesthesiology · 41d
Cleared Jun 05, 1986
CREATINE PHROSPHOKINASE (CK) PROCEDURE
K861665 · CGS
Data Medical Associates, Inc.
Chemistry · 36d
Cleared Jun 05, 1986
GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
K861893 · JXL
Hi Chem, Inc.
Chemistry · 20d
Cleared Jun 05, 1986
SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER
K862042 · KFZ
Associated Mills, Inc.
Anesthesiology · 8d
Cleared Jun 05, 1986
TITERTEK MICROPLATE WASHER S-12
K862066 · JTC
Flow Laboratories, Inc.
Microbiology · 6d
Cleared Jun 05, 1986
E. T. TAPE ENDOTRACHEAL TUBE HOLDER
K862084 · CBH
B&B Medical Technologies, Inc.
Anesthesiology · 3d
Cleared Jun 04, 1986
TE-25 COAGURO METER
K854686 · JBP
Future Impex Corp.
Hematology · 196d
Cleared Jun 04, 1986
ERMA HB-METER MODEL 303N
K854687 · KHG
Future Impex Corp.
Hematology · 196d
Cleared Jun 04, 1986
TIMELINE VENIPUNCTURE SYSTEM
K860609 · FPA
Ipax, Inc.
General Hospital · 105d
Cleared Jun 04, 1986
TIMELINE VENIPUNCTURE SYSTEM
K861182 · FPA
Ipax, Inc.
General Hospital · 65d