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
162793–162816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1981
FIX-RIGHT 90ML & 180 ML PREFILLED CONT
K811793 · KDT
Richard-Allan Medical Ind., Inc.
Hematology · 37d
Cleared Jul 31, 1981
CLEAR-MOUNT
K811799 · LEB
Richard-Allan Medical Ind., Inc.
Hematology · 37d
Cleared Jul 31, 1981
JAPANESE HOTZIE
K811803 · IMD
Consolidated Health & Sports Prod.
Physical Medicine · 37d
Cleared Jul 31, 1981
TRIANGULAR BANDAGE
K811814 · NAB
Abco Dealers, Inc.
General & Plastic Surgery · 35d
Cleared Jul 31, 1981
SKIN SCRUB KITS
K811855 · KDD
Oem Medical Div.
General & Plastic Surgery · 30d
Cleared Jul 31, 1981
SIGMA PROCEDURE 265-UV
K811864 · CED
Sigma Chemical Co.
Chemistry · 30d
Cleared Jul 31, 1981
VMA PEDIATRIC APNEA MATTRESS
K811865 · BZQ
Vickers America Medical Corp.
Anesthesiology · 30d
Cleared Jul 31, 1981
CORDIS DOW SERA FLO TM TRANSDUCER PROT
K811892 · FIB
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Jul 31, 1981
ARGYLE TARTAN TRACHEAL TUBE
K811937 · BTR
Sherwood Medical Co.
Anesthesiology · 25d
Cleared Jul 31, 1981
AUTONORM & NERV-A-NORM
K811956 · KNM
Autonomic Equipment Supply Co,
Physical Medicine · 22d
Cleared Jul 31, 1981
FORDER RETRACTOR
K811973 · KOA
Surgemed Marketing, Inc.
Gastroenterology & Urology · 21d
Cleared Jul 31, 1981
HEMASITE ACCESS MONITOR (TENT.) #RS-8200
K811977 · KOC
Renal Systems, Inc.
Gastroenterology & Urology · 18d
Cleared Jul 31, 1981
VOLUMETRIC INFUSION PUMP
K812021 · FRN
American Edwards Laboratories
General Hospital · 11d
Cleared Jul 31, 1981
ZEE MANUAL RESUSCITATOR
K812022 · BTM
Zee Medical Products Co., Inc.
Anesthesiology · 11d
Cleared Jul 31, 1981
INFUSION PUMP MODEL 200/201
K812042 · FRN
Medix Medical Electronics (U.S.A.), Inc.
General Hospital · 10d
Cleared Jul 31, 1981
VANCE CYSTOSCOPIC
K812057 · FBK
Vance Products, Inc.
Gastroenterology & Urology · 10d
Cleared Jul 31, 1981
AKRON URINARY DRAINAGE BAT
K812058 · KNX
Latex Ind., Inc.
Gastroenterology & Urology · 10d
Cleared Jul 30, 1981
VERI-FIER
K811351 · GZJ
Verite
Neurology · 78d
Cleared Jul 28, 1981
BALLOON CATHETER
K810689
Surgimed Corp.
General & Plastic Surgery · 137d
Cleared Jul 28, 1981
CARDIAC 1000 TM
K811094 · JAA
American Edwards Laboratories
Radiology · 98d
Cleared Jul 28, 1981
PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS
K811563 · EJS
Williams Gold Refining Co., Inc.
Dental · 54d
Cleared Jul 28, 1981
THE PLACER
K811582 · EID
Cavitron Corp.
Dental · 53d
Cleared Jul 28, 1981
KULZER TRANSLUX VISIBLE LIGHT CURING
K811668 · EBZ
Kulzer, Inc.
Dental · 43d
Cleared Jul 28, 1981
37% FORMALDEHYDE
K811794 · IGG
Richard-Allan Medical Ind., Inc.
Hematology · 34d