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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
108025–108048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1994
SBP DENTAL UNIT
K934436 · EIA
Northland Dental Engineering
Dental · 283d
Cleared Jun 02, 1994
ENA EIA TEST KIT
K935413 · LLL
David A. Fuccillo, Ph.D.
Immunology · 205d
Cleared Jun 02, 1994
HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER
K940269 · EXJ
Hollister, Inc.
Gastroenterology & Urology · 132d
Cleared Jun 02, 1994
TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES
K940347 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 128d
Cleared Jun 02, 1994
QMS CARBAMAZEPINE ASSAY
K940374 · KLT
Seradyn, Inc.
Toxicology · 127d
Cleared Jun 02, 1994
QMS GENTAMICIN ASSAY
K940376 · LCD
Seradyn, Inc.
Toxicology · 127d
Cleared Jun 02, 1994
NAVIGATOR-MP CATHETER LOCATION INSTRUMENT
K940385 · FOZ
Navion Biomedical Corp.
General Hospital · 127d
Cleared Jun 02, 1994
LIPASE REAGENT SYSTEM
K940457 · CET
Medical Diagnostic Technologies, Inc.
Chemistry · 121d
Cleared Jun 02, 1994
ALEXANTRIPTOR
K940461 · GEX
Servicetrends, Inc.
General & Plastic Surgery · 120d
Cleared Jun 02, 1994
PREDICTOR HOME PREGNANCY TEST
K940637 · LCX
Organon Teknika Corp.
Chemistry · 108d
Cleared Jun 02, 1994
BARD(R) EXPANDED PTFE VASCULAR GRAFT
K940816 · DSY
C.R. Bard, Inc.
Cardiovascular · 100d
Cleared Jun 02, 1994
USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500
K940912 · LDJ
U.S. Drug Testing, Inc.
Toxicology · 97d
Cleared Jun 02, 1994
REFLEX EGR
K940955 · GEI
Ricard-Allan Medical
General & Plastic Surgery · 93d
Cleared Jun 02, 1994
MODEL MCC - MKIV MICRO COMPUTER CONTROLS
K940972 · ITI
Invacare Corp.
Physical Medicine · 91d
Cleared Jun 02, 1994
UNISTEP HCG PREGNANCY TEST STRIP
K941090 · DHA
Biotech Atlantic, Inc.
Chemistry · 86d
Cleared Jun 02, 1994
ACCESS PROLACTIN
K941175 · CFT
Bio-Rad Laboratories, Inc.
Chemistry · 80d
Cleared Jun 02, 1994
WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE
K941305 · FBK
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 02, 1994
CEDIA DAU COCAINE ASSAY
K941310 · DIO
Microgenics Corp.
Toxicology · 80d
Cleared Jun 02, 1994
CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676
K942199 · EBZ
Rolence Enterprise Co. , Ltd.
Dental · 28d
Cleared Jun 02, 1994
ORION SUCTION CATHETER KIT WITH STERILE WATER
K942273 · GBX
Regulatory & Marketing Services, Inc.
General & Plastic Surgery · 23d
Cleared Jun 02, 1994
ORION SUCTION CATHETER KIT WITH STERILE SALINE
K942274 · GBX
Regulatory & Marketing Services, Inc.
General & Plastic Surgery · 23d
Cleared Jun 02, 1994
LORREX GAUZE SPONGES SPECIALTY
K942314 · EFQ
Lorrex Health Products
General & Plastic Surgery · 20d
Cleared Jun 01, 1994
MODEL 26-0375, ELECTROSURGICAL GENERATOR
K931541 · HGI
Cameron-Miller, Inc.
Obstetrics & Gynecology · 429d
Cleared Jun 01, 1994
KIT PAK INCONTINENT SKIN CARE KIT
K932310 · EYQ
Kit Pak, Inc.
Gastroenterology & Urology · 386d