FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
86473–86496 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1999
KLEENHANDS POWDERED LATEX EXAMINATION GLOVES
K990527 · LYY
Ssn Gloves (M) Sdn Bhd
General Hospital · 63d
Cleared Apr 23, 1999
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
K990584 · EFQ
Broadline Medical Industries
General & Plastic Surgery · 59d
Cleared Apr 23, 1999
CAVIT LC
K990982 · EBF
Espe Dental AG
Dental · 30d
Cleared Apr 23, 1999
RAPIDFLAP CRANIAL CLAMP
K991029 · GXN
Walter Lorenz Surgical, Inc.
Neurology · 25d
Cleared Apr 23, 1999
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT...
K991044 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 24d
Cleared Apr 23, 1999
PBN DRAINAGE CATHETER GUIDEWIRES
K991097 · KNY
Medical Device Technologies, Inc.
Gastroenterology & Urology · 22d
Cleared Apr 23, 1999
LYSTA LC CURING LIGHT, MODEL LC 2500C/BA
K991138 · EBZ
Lysta A/S
Dental · 18d
Cleared Apr 23, 1999
MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN...
K991294 · KZE
Medi-Ject Corp.
General Hospital · 8d
Cleared Apr 22, 1999
FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM
K990214 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 90d
Cleared Apr 22, 1999
AVIA PAIN MEDICATION DELIVERY SYSTEM
K990312 · MEA
Amtec Medical
General Hospital · 80d
Cleared Apr 22, 1999
ETEST FOR CEFUROXIME
K990722 · JWY
Ab Biodisk
Microbiology · 48d
Cleared Apr 22, 1999
BI-DIRECTIONAL TUNNELER
K991027 · DSY
Impra, Inc.
Cardiovascular · 24d
Cleared Apr 22, 1999
CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
K991195 · BTL
O-Two Systems Intl., Inc.
Anesthesiology · 14d
Cleared Apr 21, 1999
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS
K982413 · KDI
Gambro Healthcare
Gastroenterology & Urology · 282d
Cleared Apr 21, 1999
ENSITE 3000 SYSTEM
K983456 · MTD
Endocardial Solutions, Inc.
Cardiovascular · 203d
Cleared Apr 21, 1999
THORAX FD AND MULTIX FD
K983732 · MQB
Siemens Medical Solutions USA, Inc.
Radiology · 181d
Cleared Apr 21, 1999
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION
K984156 · JAK
Shimadzu Medical Systems
Radiology · 153d
Cleared Apr 21, 1999
PVS BASICS
K984436 · HQD
Paragon Vision Sciences
Ophthalmic · 128d
Cleared Apr 21, 1999
SHEATHES (NON-LATEX), STERILE
K990175 · ITX
Sheathing Technologies, Inc.
Radiology · 92d
Cleared Apr 21, 1999
SERIM BLOOD LEAK TEST STRIP
K990206 · FJD
Serim Research Corp.
Gastroenterology & Urology · 90d
Cleared Apr 21, 1999
PDQ AND PDQ-TI ABUTMENT
K990367 · DZE
Vident
Dental · 75d
Cleared Apr 21, 1999
DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950
K990371 · FMI
Post Medical, Inc.
General Hospital · 72d
Cleared Apr 21, 1999
CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR...
K990757 · LPL
Cantor & Silver , Ltd.
Ophthalmic · 44d
Cleared Apr 21, 1999
URETERAL ACCESS SHEATH SET
K990775 · FED
Applied Medical Resources
Gastroenterology & Urology · 43d