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
150313–150336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1984
ELASTIC BANDAGE
K843056 · GAX
Sterile Medical Systems
General & Plastic Surgery · 123d
Cleared Dec 04, 1984
UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM
K843090 · FPA
Geneva Laboratories, Inc.
General Hospital · 120d
Cleared Dec 04, 1984
MINUTEMAN CO2 MICROSURGICAL LASER OTO
K843514 · EWG
American Surgical Laser, Inc.
Ear, Nose, Throat · 90d
Cleared Dec 04, 1984
VENESECTION TRAY, ADULT 6050
K843627 · FSM
Pro-Lab, Inc.
General & Plastic Surgery · 81d
Cleared Dec 04, 1984
RESPIRATION & HEART RATE MONITOR 530
K843681 · BZQ
Tri-Med, Inc.
Anesthesiology · 77d
Cleared Dec 04, 1984
BIOSELF TM 110
K843699 · LHD
Bioself, Inc.
Obstetrics & Gynecology · 75d
Cleared Dec 04, 1984
CAB2 COMPUTER ASSISTED BIOFEEDBACK
K843738 · HCC
Discrete Data Systems, Inc.
Neurology · 70d
Cleared Dec 04, 1984
TRANSLUX CL
K843823 · EBZ
Kulzer, Inc.
Dental · 67d
Cleared Dec 04, 1984
HE TEST
K843843 · BSE
Erich Jaeger, Inc.
Anesthesiology · 64d
Cleared Dec 04, 1984
RESPIRONICS SLEEPEASY NASAL CPAP SYS
K843889 · BYE
Respironics, Inc.
Anesthesiology · 63d
Cleared Dec 04, 1984
WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT
K844196 · KME
Biological & Environmental Control...
General Hospital · 35d
Cleared Dec 04, 1984
TRACHEAL TUBE, REINFORCED, CUFFED
K844296 · BTR
Sheridan Catheter Corp.
Anesthesiology · 28d
Cleared Dec 04, 1984
OXYGEN CONCENTRATOR
K844328 · CAW
Hospitak, Inc.
Anesthesiology · 27d
Cleared Dec 04, 1984
DYNASCOPE MONITOR DS-800
K844348 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 35d
Cleared Dec 04, 1984
MEDIPART FILTER & TUBING MP-02X
K844491 · CAH
Medipart Jerry Alexander
General Hospital · 14d
Cleared Dec 04, 1984
MEDIPART BACTERIA FILTER MP-30X
K844492 · CAH
Medipart Jerry Alexander
General Hospital · 14d
Cleared Dec 04, 1984
MEDIPART FACE MASK & FILTER MP-30XM
K844493 · BSJ
Medipart Jerry Alexander
Anesthesiology · 14d
Cleared Dec 04, 1984
MEDIPART FACE MASK MP-XM
K844494 · BSJ
Medipart Jerry Alexander
Anesthesiology · 14d
Cleared Dec 03, 1984
PULSE GENERATOR 689, 689B & 689L
K841225 · DXY
Siemens Elema AB
Cardiovascular · 256d
Cleared Dec 03, 1984
PULSE GENERATOR 686, 686B 686L
K841230 · DXY
Siemens Elema AB
Cardiovascular · 256d
Cleared Dec 03, 1984
PULSE GENERATOR 696, 696B & 696L
K841232 · DXY
Siemens Elema AB
Cardiovascular · 256d
Cleared Dec 03, 1984
DEL MAR AVIONICS 5509 NEURO-SCANNER
K841653 · GWQ
Del Mar Avionics
Neurology · 224d
Cleared Dec 03, 1984
EASY EYES TM LENS CARRYING CASE
K841881 · HPX
Eaton Medical Corp.
Ophthalmic · 210d
Cleared Dec 03, 1984
FLUOROSKAN
K842049 · JZT
Flow Laboratories, Inc.
Immunology · 195d