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
131113–131136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 1989
POSI SHIELD (PATIENT EXAMINATION GLOVES)
K892474 · LYY
West Chester Marketing, Inc.
General Hospital · 31d
Cleared May 08, 1989
POSI SHIELD (PATIENT EXAMINATION GLOVES)
K892475 · LYY
Clinical Supply
General Hospital · 31d
Cleared May 08, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892476 · LYY
Serata Glove Industries Sdn. Bhd.
General Hospital · 31d
Cleared May 08, 1989
SAFETEX & SUNTEX PATIENT EXAMINATION GLOVES
K892478 · LYY
P.T. Latexindo Prautama
General Hospital · 31d
Cleared May 05, 1989
STEREOTACTIC BIOPSY ATTACHMENT
K884107 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 218d
Cleared May 05, 1989
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM
K884564 · CAC
Shiley, Inc.
Anesthesiology · 185d
Cleared May 05, 1989
LOW ADSORPTION ADMINISTRATION SET
K885031 · FPA
3M Company
General Hospital · 151d
Cleared May 05, 1989
BACTERIA FILTER
K890035 · CAH
Hudson Oxygen Therapy Sales Co.
General Hospital · 121d
Cleared May 05, 1989
PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION
K890268 · KPE
Biomedical Dynamics, Inc.
General Hospital · 107d
Cleared May 05, 1989
DIVERSI-MED STERILE LATEX SURGEON'S GLOVES
K890289 · KGO
Diversi Group, Inc.
General Hospital · 106d
Cleared May 05, 1989
SKIN SCRUB KIT
K890570 · LRO
Kit Pak, Inc.
General & Plastic Surgery · 88d
Cleared May 05, 1989
ACCUTHERM PTS-200
K890575 · DWJ
Medical Repackers Co.
Cardiovascular · 88d
Cleared May 05, 1989
HYDRODENT ANTIPLAQUE SYSTEM
K890600 · EFS
Hydrodent Laboratories, Inc.
Dental · 88d
Cleared May 05, 1989
OROSPHERE PLUS
K890682 · EJJ
Jeneric/Pentron, Inc.
Dental · 85d
Cleared May 05, 1989
CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE)
K890822 · BZO
Ventlab Corp.
Anesthesiology · 77d
Cleared May 05, 1989
ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER
K890823 · FLL
Sheridan Catheter Corp.
General Hospital · 77d
Cleared May 05, 1989
LD1 ISOENZYME REAGENT KIT
K890996 · JGF
Trace Scientific , Ltd.
Chemistry · 67d
Cleared May 05, 1989
IQ ALBUMIN
K891375 · CIX
Bd Becton Dickinson Vacutainer...
Chemistry · 57d
Cleared May 05, 1989
DISPOSABLE THERMOPLASTIC ANESTH BREATHING CIRCUITS
K891479 · CAI
Anetec, Inc.
Anesthesiology · 50d
Cleared May 05, 1989
ANGIOTEC FMX-2220 SYSTEM
K891485 · LMB
Andros Analyzers, Inc.
Radiology · 49d
Cleared May 05, 1989
INTRAVASCULAR ADMINISTRATION SET
K891919 · FMI
Multi-Med, Inc.
General Hospital · 39d
Cleared May 05, 1989
ACTIDERM*-OPAQUE
K892232 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 31d
Cleared May 05, 1989
MODERN (STERILE SURGEON'S GLOVES)
K892285 · KGO
Firestone Financial Corp.
General Hospital · 29d
Cleared May 05, 1989
KENDALL CURITY URINARY DRAINAGE BAGS
K892433 · KNX
The Kendal Co.
Gastroenterology & Urology · 25d