FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
135217–135240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1988
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
K882542 · JJY
Bio-Rad
Chemistry · 30d
Cleared Jul 21, 1988
ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.
K882549 · FCG
Acuson Corp.
Gastroenterology & Urology · 31d
Cleared Jul 21, 1988
AUGUSTINE INTUBATION GUIDE(TM)
K882659 · CCW
Augustine Medical, Inc.
Anesthesiology · 23d
Cleared Jul 20, 1988
ORMON DIGITAL FEVER THERMOMETER MODEL MC-3B
K881446 · FLL
Ormon Electronics, Inc.
General Hospital · 105d
Cleared Jul 20, 1988
JIMMY JOHN III
K881720 · KPL
Colon Therapeutics
Gastroenterology & Urology · 90d
Cleared Jul 20, 1988
MODEL 20 KY KRYPTON YELLOW LASER
K881940 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 72d
Cleared Jul 20, 1988
SYNCOR (R) MODEL S-801 ECG ELECTRODE
K882216 · DRX
Lectec Corp.
Cardiovascular · 55d
Cleared Jul 19, 1988
MULTIPURPOSE TRANSDUCER RANGE
K874192 · IYO
Pie Data Medical BV
Radiology · 279d
Cleared Jul 19, 1988
IONODENT (TOOTHBRUSH)
K874443 · EFW
U.S. Apatite Corp.
Dental · 265d
Cleared Jul 19, 1988
SORBSAN TOPICAL WOUND DRESSING
K881854 · FRO
E.G. Dick & Assoc.
General & Plastic Surgery · 77d
Cleared Jul 19, 1988
C-E BRUSH
K881921 · HHT
Surgipath Medical Industries, Inc.
Obstetrics & Gynecology · 71d
Cleared Jul 19, 1988
PCA MODULAR TOTAL KNEE SYS-ALL PLAS PATELLAR COMP
K881982 · JWH
Howmedica Corp.
Orthopedic · 68d
Cleared Jul 19, 1988
HEADREST, PATIENT COMFORT
K882332 · KME
Surgic Aid, Inc.
General Hospital · 43d
Cleared Jul 19, 1988
ROD, IRRIGATOR SUPPORTING, TELESCOPING TYPE
K882493 · FOX
Cambridge Technologies, Inc.
General Hospital · 33d
Cleared Jul 19, 1988
DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2002
K882774 · KIT
J R Scientific
Pathology · 14d
Cleared Jul 19, 1988
DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2023
K882775 · KIT
J R Scientific
Pathology · 14d
Cleared Jul 19, 1988
DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2014
K882776 · KIT
J R Scientific
Pathology · 14d
Cleared Jul 19, 1988
DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2004
K882777 · KIT
J R Scientific
Pathology · 14d
Cleared Jul 19, 1988
BASAL MEDIUM EAGEL, CATALOG NO. 200-2044
K882778 · KIT
J R Scientific
Pathology · 14d
Cleared Jul 19, 1988
BASAL MEDIUM EAGLE CATALOG NO. 200-2052
K882779 · KIT
J R Scientific
Pathology · 14d
Cleared Jul 19, 1988
NUTRIENT MIXTURE F-10 (HAM), NO. 200-2061
K882780 · KIT
J R Scientific
Pathology · 14d
Cleared Jul 19, 1988
RPMI-1640 MEDIUM, CATALOG NO. 200-2077
K882781 · KIT
J R Scientific
Pathology · 13d
Cleared Jul 19, 1988
RPMI-1640 MEDIUM, CATALOG NO. 200-2081
K882782 · KIT
J R Scientific
Pathology · 13d
Cleared Jul 19, 1988
BASAL MEDIUM EAGLE (BME) DIPLOID, NO. 200-2043
K882783 · KIT
J R Scientific
Pathology · 13d