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
108385–108408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1994
E-Z PEG
K921680 · KNT
Mill-Rose Laboratory
Gastroenterology & Urology · 758d
Cleared May 06, 1994
BASIC SHOULDER CPM
K931128 · BXB
Danninger Medical Technology, Inc.
Physical Medicine · 427d
Cleared May 06, 1994
REFLECTION ACETABULAR COMPONENT
K932755 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 350d
Cleared May 06, 1994
HEMOLAB HEPARICHROM ASSAY
K934274 · KFF
Biomerieux Vitek, Inc.
Hematology · 248d
Cleared May 06, 1994
QUADTRAX
K935201 · ITI
Body Bike, Inc.
Physical Medicine · 191d
Cleared May 06, 1994
KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS
K940049 · HET
Baxter Healthcare Corp
Obstetrics & Gynecology · 121d
Cleared May 06, 1994
ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM
K940481 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 93d
Cleared May 06, 1994
SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH
K940545 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared May 06, 1994
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
K940581 · BTM
Respironics, Inc.
Anesthesiology · 87d
Cleared May 06, 1994
KTI HY-Q(TM) WOUND DRESSING
K940738 · KMF
Kingston Technologies, Inc.
General & Plastic Surgery · 78d
Cleared May 06, 1994
TROCAR AND CANNULA
K941250 · GCJ
Debusk Technology Corp.
General & Plastic Surgery · 52d
Cleared May 06, 1994
OCCUPATIONAL THERAPY TABLES
K941281 · INQ
Med Mart, Inc.
Physical Medicine · 51d
Cleared May 06, 1994
MODEL 747 AND 747-30 EXAM/TREATMENT TABLE
K941720 · INQ
Tri W-G, Inc.
Physical Medicine · 29d
Cleared May 06, 1994
STRYKER 5050 STRECHAIR
K941738 · INM
Stryker Medical
Physical Medicine · 29d
Cleared May 06, 1994
CAT SCOOTER
K941966 · INI
Genus Medical, Inc.
Physical Medicine · 14d
Cleared May 05, 1994
STAIR CLIMBER
K926278 · ISD
Henley Intl.
Physical Medicine · 507d
Cleared May 05, 1994
UPPER BODY EXERCISER
K926279 · ISD
Henley Intl.
Physical Medicine · 507d
Cleared May 05, 1994
ABDOMINAL / THORACIC PATIENT DRAPE
K930815 · KKX
Custom Medical Products, Ltd.
General Hospital · 442d
Cleared May 05, 1994
CATH-FINDER
K931073 · FOZ
Pharmacia Deltec, Inc.
General Hospital · 429d
Cleared May 05, 1994
CO-CR ANSWER FEMORAL COMPONENT
K931194 · JDG
Biomet, Inc.
Orthopedic · 422d
Cleared May 05, 1994
SIDEKICK II
K931231 · INI
Pride Health Care, Inc.
Physical Medicine · 421d
Cleared May 05, 1994
SURGICAL DRAPE
K931418 · KKX
Custom Medical Products, Ltd.
General Hospital · 409d
Cleared May 05, 1994
HEAD SHEET
K931455 · KKX
Custom Medical Products, Ltd.
General Hospital · 408d
Cleared May 05, 1994
SURGICAL TROCARS
K933458 · GCJ
Ximed Medical Systems
General & Plastic Surgery · 295d