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
122737–122760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 1991
FLEXIFLO STOMATE EXTENSION TUBE
K902623 · KNT
Abbott Laboratories
Gastroenterology & Urology · 231d
Cleared Jan 31, 1991
WALLACH FLEXIBLE ENDOMETRIAL SAMPLER
K902693 · HFF
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 226d
Cleared Jan 31, 1991
PC-BEADS POSTCOITAL TEST
K902995 · HHT
Microscopy Research Innovations
Obstetrics & Gynecology · 206d
Cleared Jan 31, 1991
AUTO FIRST-AID KIT FOR AMERICA
K903393 · LRR
Hisler-Radke, Inc.
General & Plastic Surgery · 188d
Cleared Jan 31, 1991
VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD)
K903847 · LYZ
Zest Mark Industrial Co., Ltd.
General Hospital · 163d
Cleared Jan 31, 1991
SIL-MED T-TUBE DRAIN
K903989 · HFL
Sil-Med Corp.
Obstetrics & Gynecology · 155d
Cleared Jan 31, 1991
TRACET AG 4000
K904512 · DRX
Lectec Corp.
Cardiovascular · 121d
Cleared Jan 31, 1991
SURGICARE STERILE SURGICAL GLOVES
K904972 · KGO
Kanam Latex Industries Pvt. , Ltd.
General Hospital · 99d
Cleared Jan 31, 1991
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
K905000 · HEM
Corometrics Medical Systems, Inc.
Obstetrics & Gynecology · 85d
Cleared Jan 31, 1991
ORAL PHARYNGEAL CLEANSING DEVICE
K905011 · EIA
Concord/Portex
Dental · 85d
Cleared Jan 31, 1991
IODOSORB GEL
K905069 · KOZ
Perstorp AB C/O Robert Joel Slomoff
General & Plastic Surgery · 83d
Cleared Jan 31, 1991
MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER
K905080 · LFJ
Kendall Healthcare Products Co....
Gastroenterology & Urology · 79d
Cleared Jan 31, 1991
PEGASUS WITH ACCESSORIES
K905082 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 79d
Cleared Jan 31, 1991
JAIN SUTURE/VESIBAND ORGANIZER
K905105 · MDM
Jain Surgical Equipment, Inc.
General & Plastic Surgery · 79d
Cleared Jan 31, 1991
AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER
K905106 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 79d
Cleared Jan 31, 1991
FLOWERS CHIN IMPLANT
K905267 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 71d
Cleared Jan 31, 1991
FLOWERS JOWL IMPLANT
K905268 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 71d
Cleared Jan 31, 1991
UST-969-5 CONVEX TRANSDUCER
K905391 · ITX
Ge Medical Systems Information...
Radiology · 62d
Cleared Jan 31, 1991
ELMED PNEUMOMAT DIGITAL
K905417 · HIF
Elmed, Inc.
Obstetrics & Gynecology · 58d
Cleared Jan 31, 1991
FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE
K905440 · GAS
United States Surgical, A Division of...
General & Plastic Surgery · 58d
Cleared Jan 31, 1991
UBI MAGIWEL CORTISOL QUANTITATIVE
K905473 · CGR
United Biotech, Inc.
Chemistry · 56d
Cleared Jan 31, 1991
KINETIC AMYLASE DETERMINATION
K905651 · JFJ
Biochemical Trade, Inc.
Chemistry · 44d
Cleared Jan 31, 1991
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
K905661 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 44d
Cleared Jan 31, 1991
FLEXIBLE ENDOSCOPIC ELECTRODE
K905731 · FAS
Applied Urology, Inc.
Gastroenterology & Urology · 38d