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
140497–140520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1987
EXTERNAL Y VALVE 5C4198
K870145 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 56d
Cleared Mar 10, 1987
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
K870155 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 56d
Cleared Mar 10, 1987
VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044
K870259 · JHI
Leeco Diagnostics, Inc.
Chemistry · 46d
Cleared Mar 10, 1987
EASY-TEST CREATINE KINASE-MB (CK-MB) #16615
K870462 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Mar 10, 1987
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
K870520 · CGJ
Hybritech, Inc.
Chemistry · 32d
Cleared Mar 10, 1987
VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET
K870555 · KOB
Van-Tec, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 10, 1987
VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET
K870556 · KOB
Van-Tec, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 10, 1987
VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER
K870694 · KOD
Van-Tec, Inc.
Gastroenterology & Urology · 19d
Cleared Mar 10, 1987
VAN-TEC URETHRAL DILATATION SYSTEM
K870695 · KOE
Van-Tec, Inc.
Gastroenterology & Urology · 19d
Cleared Mar 10, 1987
VAN-TEC ONE STEP URETERAL DILATATION CATHETER
K870697 · EZN
Van-Tec, Inc.
Gastroenterology & Urology · 19d
Cleared Mar 10, 1987
RAT LIVER NUCLEI TEST SYSTEM
K870732 · DHN
Val Tech Diagnostics, Inc.
Immunology · 13d
Cleared Mar 10, 1987
TEFLON BIOPSY CATHETER W/TIP ANGLE
K870734 · KNW
Van-Tec, Inc.
Gastroenterology & Urology · 13d
Cleared Mar 09, 1987
RADIATION ONCOLOGY COMPUTER SYS TREATMENT PLANNING
K862643
Pacific Physics, Inc.
Radiology · 241d
Cleared Mar 09, 1987
AMUKIN-50% FOR CAPD Y-SET
K862928 · FKX
Amuchina Intl., Inc.
Gastroenterology & Urology · 220d
Cleared Mar 09, 1987
BONE MINERAL DENSITOMETRY OPTION B7918AA
K863618 · KGI
General Electric Co.
Radiology · 174d
Cleared Mar 09, 1987
BAUMAN CPR/RESPIRATOR
K864308 · BTM
General Medical Products, Inc.
Anesthesiology · 126d
Cleared Mar 09, 1987
HOOD BIFURCATED T-TUBE
K864533 · BTR
Hood Laboratories
Anesthesiology · 111d
Cleared Mar 09, 1987
PHOENIX-C ANESTHESIA MACHINE
K864644 · BSZ
American Anesthesia, Inc.
Anesthesiology · 103d
Cleared Mar 09, 1987
DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
K864956 · GZJ
La Jolla Technology, Inc.
Neurology · 81d
Cleared Mar 09, 1987
CO2 LASER BRONCHOSCOPE SET
K870063 · EOQ
Tti Medical
Ear, Nose, Throat · 61d
Cleared Mar 09, 1987
ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100
K870269 · GEI
American Bentley
General & Plastic Surgery · 45d
Cleared Mar 09, 1987
COMPANION 2800 PORTABLE VOLUME VENTILATOR
K870275 · CBK
Puritan Bennett Corp.
Anesthesiology · 41d
Cleared Mar 09, 1987
HAWKINS BREAST LOCALIZATION NEEDLE
K870523 · GDM
N-S Medical Products
General & Plastic Surgery · 31d
Cleared Mar 09, 1987
VARIOUS TYES OF SURGICAL GARMENTS
K870617 · FYF
Greene International Corp.
General & Plastic Surgery · 25d