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
102169–102192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 1995
MEMORYTRACE ATM MODEL 4222
K941898 · DXH
Hi-Tronics Designs, Inc.
Cardiovascular · 434d
Cleared Jun 26, 1995
PGS123 AND HVS-123
K946299 · GZJ
Skylark Device Co., Ltd.
Neurology · 181d
Cleared Jun 26, 1995
OPTI PADS
K950940 · LYL
Karlen Mfg., Inc.
Ophthalmic · 119d
Cleared Jun 26, 1995
ANGIOSCAN (AS STAND ALONE INSTRUMENT)
K951132 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 105d
Cleared Jun 26, 1995
SPINE TUNER POSTURE TRAINER
K951244 · LZW
Dan Kline
Physical Medicine · 105d
Cleared Jun 26, 1995
BOSTON CONTACT LENS CASE
K951552 · LRX
Polymer Technology Corp.
Ophthalmic · 83d
Cleared Jun 26, 1995
SUNGLASSES
K951815 · HQY
Fung Won Optical Mfg. Co.
Ophthalmic · 91d
Cleared Jun 26, 1995
MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15
K952232 · LNH
Medrad, Inc.
Radiology · 45d
Cleared Jun 26, 1995
MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-15
K952235 · LNH
Medrad, Inc.
Radiology · 45d
Cleared Jun 26, 1995
ROBERT B. SCOTT PLASTIC ARTIFICAL
K952538 · HQH
Robert B. Scott Ocularists of...
Ophthalmic · 26d
Cleared Jun 26, 1995
SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE
K952556 · LYY
Aladan Corp.
General Hospital · 24d
Cleared Jun 23, 1995
EW-10 AND EW-20
K915402 · FEB
Olympus Corp.
General Hospital · 1297d
Cleared Jun 23, 1995
DYNAPULSE 5000A (DP5000A)
K945111 · DXN
Pulse Metric, Inc.
Cardiovascular · 248d
Cleared Jun 23, 1995
CITATION DELTA SCOPE
K945390 · HRX
Citation Medical Corp.
Orthopedic · 232d
Cleared Jun 23, 1995
VINYL POWDER-FREE EXAMINATION GLOVES
K946021 · LYZ
Wilson Glove Products Co., Ltd.
General Hospital · 196d
Cleared Jun 23, 1995
IGFBP-3
K946247 · CFL
Nichols Institute
Chemistry · 183d
Cleared Jun 23, 1995
MUSCLESENSE ELECTROMYOGRAPHY DEVICE
K951350 · HCC
Smith and Nephew Donjoy, Inc.
Neurology · 91d
Cleared Jun 23, 1995
V-CATH PERCUTANEOUS INTRODUCER KIT
K951384 · KZH
Hdc Corp.
General Hospital · 88d
Cleared Jun 23, 1995
MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS...
K952290 · JOS
Mist, Inc.
General & Plastic Surgery · 38d
Cleared Jun 23, 1995
MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES
K952323 · JOS
Mist, Inc.
General & Plastic Surgery · 36d
Cleared Jun 23, 1995
DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL
K952412 · DIF
Dupont Medical Products
Toxicology · 31d
Cleared Jun 23, 1995
PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER
K952414 · KNY
Acacia Laboratories, Inc.
Gastroenterology & Urology · 31d
Cleared Jun 23, 1995
MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A
K952484 · LMD
Toshiba America Medical Systems, In.C
Radiology · 24d
Cleared Jun 23, 1995
STERI-OSS SELF TAPING IMPLANT
K952644 · DZE
Steri-Oss, Inc.
Dental · 14d