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
108481–108504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1994
VENSHIELD
K941813 · BYD
Cybermedic, Inc.
Anesthesiology · 21d
Cleared May 02, 1994
MICRO-PAP(TM) KIT
K912325 · HHT
Micro-Pap Corp.
Obstetrics & Gynecology · 1074d
Cleared May 02, 1994
MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION
K921370 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 773d
Cleared May 02, 1994
MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT
K921652 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 756d
Cleared May 02, 1994
BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA
K921722 · HET
Bard Reproductive Systems
Obstetrics & Gynecology · 753d
Cleared May 02, 1994
BRANEMARK SYST. HAND INST. DIA 297 & SDIA 276
K925483 · DZE
Nobelpharma USA, Inc.
Dental · 549d
Cleared May 02, 1994
VYGON - ENTERAL FEEDING TUBE - POLYURETHANE
K925854 · KNT
Vygon Corp.
Gastroenterology & Urology · 531d
Cleared May 02, 1994
I.V. ADMINISTRATION SET
K926448 · FPA
Gainor Medical Europe, Ltd.
General Hospital · 495d
Cleared May 02, 1994
LOW PROFILE MID CROSS BRACING
K931225 · KWP
Advanced Spine Fixation Systems, Inc.
Orthopedic · 418d
Cleared May 02, 1994
COATEST(R) ANTITHROMBIN III, MODIFICATION
K931420 · JBQ
Kabi Pharmacia Hepar, Inc.
Hematology · 419d
Cleared May 02, 1994
DISPOSABLE SURGICAL MASK (MODIFIED)
K931580 · FXX
Bam Corp., Ltd.
General Hospital · 398d
Cleared May 02, 1994
PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH
K932198 · LJS
Pharmacia Deltec, Inc.
General Hospital · 361d
Cleared May 02, 1994
PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS
K932211 · LJS
Pharmacia Deltec, Inc.
General Hospital · 360d
Cleared May 02, 1994
PATIENT EXAMINATION GLOVES
K932283 · LYY
Eac Rubber Industries (M) Sdn. Bhd.
General Hospital · 360d
Cleared May 02, 1994
DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER
K932430 · LJS
Pharmacia Deltec, Inc.
General Hospital · 347d
Cleared May 02, 1994
PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE
K932433 · LJS
Pharmacia Deltec, Inc.
General Hospital · 347d
Cleared May 02, 1994
PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH.
K932464 · LJS
Pharmacia Deltec, Inc.
General Hospital · 346d
Cleared May 02, 1994
MINIX/MINIX ST PULSE GENERATORS
K932884 · DXY
Medtronic Vascular
Cardiovascular · 322d
Cleared May 02, 1994
ELMED ESU 300 M/M AND DIGITAL
K932938 · GEI
Elmed, Inc.
General & Plastic Surgery · 320d
Cleared May 02, 1994
COHERENT VERSAPULSE 2.1 HOLMIUM SURGICAL LASERS
K932981 · GEX
Coherent Medical Group
General & Plastic Surgery · 318d
Cleared May 02, 1994
VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600
K934482 · FLL
Vital Signs, Inc.
General Hospital · 230d
Cleared May 02, 1994
INSTAVAC II
K934976 · BTA
Aeros Instruments, Inc.
General & Plastic Surgery · 195d
Cleared May 02, 1994
EPIDURAL ANESTHESIA TRAY
K935245 · CAZ
Spinal Specialties, Inc.
Anesthesiology · 182d
Cleared May 02, 1994
SM EIA TEST KIT
K935414 · LJM
David A. Fuccillo, Ph.D.
Immunology · 174d