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
112825–112848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1993
EPIDURAL MINIPACK
K924541 · BYO
Concord/Portex
Anesthesiology · 304d
Cleared Jul 09, 1993
ZEISS LASER INDIRECT OPHTHALMOSCOPE
K924588 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 302d
Cleared Jul 09, 1993
ULTRATUFF CUT RESISTANT GLOVE LINER
K925628 · LYU
Baxter Healthcare Corp
General Hospital · 245d
Cleared Jul 09, 1993
REUSABLE LIQUIDPROOF BOOTIE
K925815 · FXP
Amsco Sterile Recoveries, Inc.
General Hospital · 234d
Cleared Jul 09, 1993
MODEL 3D3 OSMOMETER
K925970 · JJM
Advanced Instruments, Inc.
Chemistry · 226d
Cleared Jul 09, 1993
CARE-E-VAC
K926566 · BTA
Aeros Instruments, Inc.
General & Plastic Surgery · 190d
Cleared Jul 09, 1993
TROCAR SHEATH ANCHOR
K930301 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 169d
Cleared Jul 09, 1993
ONIK-COHEN ACCESS SET
K930608 · KOD
Cook Urological, Inc.
Gastroenterology & Urology · 154d
Cleared Jul 09, 1993
MEDLINES REPEAT PERFORMANCE SURGICAL PACK SYSTEM
K930700 · LRO
Medline Industries, Inc.
General & Plastic Surgery · 149d
Cleared Jul 09, 1993
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT
K930787 · DQX
Advanced Surgical, Inc.
Cardiovascular · 143d
Cleared Jul 09, 1993
SYSTEMATE CREATININE TEST ITEM NUMBER 65413
K932160 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Jul 09, 1993
SUTURE SET OR LACERATION TRAYS (PACKS)
K932219 · KDD
Associated Medical Products Co.
General & Plastic Surgery · 63d
Cleared Jul 08, 1993
TUTTNAUER LSI (AUTOMATIC)
K920478 · FLE
Tuttnauer Co. , Ltd.
General Hospital · 526d
Cleared Jul 08, 1993
ACOUSTIC RHINOMETER
K921452 · BXQ
Hood Laboratories
Anesthesiology · 469d
Cleared Jul 08, 1993
COLGATE ODONTOSON ULTRASONIC SCALER
K921893 · ELC
Perio-Giene
Dental · 442d
Cleared Jul 08, 1993
E.Z. TEMEP, TEMPORARY FILLING MATERIAL
K924132 · EMA
Cosmedent, Inc.
Dental · 325d
Cleared Jul 08, 1993
BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)
K924208 · DPT
Medtronic Bio-Medicus, Inc.
Cardiovascular · 322d
Cleared Jul 08, 1993
DISPOSABLE PERFORATOR
K924242 · HBF
Codman & Shurtleff, Inc.
Neurology · 318d
Cleared Jul 08, 1993
TRANSPARENT ADHESIVE DRESSING
K924794 · KGX
Medical Concepts Development, Inc.
General & Plastic Surgery · 288d
Cleared Jul 08, 1993
THE ORTHOTRAINER
K924975 · KMY
Myofunctional Research Corp. Pty. , Ltd.
Dental · 281d
Cleared Jul 08, 1993
CONSEPSIS(TM)
K924982 · LBH
Ultradent Products, Inc.
Dental · 280d
Cleared Jul 08, 1993
IVAC SYRING PUMP MODEL 770
K925091 · FRN
Y
General Hospital · 274d
Cleared Jul 08, 1993
GLASS IONOMER CEMENT
K925207 · EMA
Milton Hodosh, M.D.
Dental · 288d
Cleared Jul 08, 1993
COMBISON(R) 311
K925354 · IYO
Kretztechnik AG
Radiology · 259d