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
110113–110136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1994
STERILE LAPAROTOMY SPONGES
K934971 · GDY
Medsurg Industries, Inc.
General & Plastic Surgery · 112d
Cleared Feb 07, 1994
ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT KITS
K935168 · CAI
Bill Olson Corp.
Anesthesiology · 103d
Cleared Feb 07, 1994
IL TEST HEPARIN (XA), PN 84699-15
K935212 · KFF
Instrumentation Laboratory CO
Hematology · 101d
Cleared Feb 07, 1994
INFINITECH BREATH EZ
K935441 · BWN
Infinitech, Inc.
General & Plastic Surgery · 87d
Cleared Feb 07, 1994
CUSTOM PLASTIC PACKS
K935622 · FRG
Associated Medical
General Hospital · 77d
Cleared Feb 04, 1994
OWENS BIOPSY FORCEPS
K924224 · HFB
Owens Precision Systems, Inc.
Obstetrics & Gynecology · 532d
Cleared Feb 04, 1994
GS-MODULAR (GOLD STANDARD - MODULAR)
K925459 · BZG
Warren E. Collins, Inc.
Anesthesiology · 463d
Cleared Feb 04, 1994
GIMBEL PUNCTURE RESISTANT SURGICAL GLOVE
K925861 · KGO
Gimbel Glove Co.
General Hospital · 442d
Cleared Feb 04, 1994
COMPUTERIZED TESTING AND EXERCISE SYSTEMS
K926313 · BXB
Henley Intl.
Physical Medicine · 416d
Cleared Feb 04, 1994
THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE
K930315 · GDJ
Thomasville Medical Assoc.
General & Plastic Surgery · 378d
Cleared Feb 04, 1994
BULLETT PERIPHERAL INFUSION CATHETER
K931027 · FOZ
Cardio-Dynamics, Inc.
General Hospital · 340d
Cleared Feb 04, 1994
CARAPACE PACKING GAUZE TRAYS
K931760 · LRO
Carapace, Inc.
General & Plastic Surgery · 302d
Cleared Feb 04, 1994
CHAKOFF ENDOSCOPY
K932627 · GCJ
Stephen Chakoff, Inc.
General & Plastic Surgery · 248d
Cleared Feb 04, 1994
NON INVASIVE VASCULAR PROGRAM
K932852 · JOB
D. E. Hokanson, Inc.
General Hospital · 239d
Cleared Feb 04, 1994
S-610 & 2-628 WHEELED SHOWER STRETCHERS
K933060 · FPO
The Anthros Medical Group
General Hospital · 227d
Cleared Feb 04, 1994
PERIO/ENDO LENS
K934002 · EIA
New Image Industries, Inc.
Dental · 172d
Cleared Feb 04, 1994
STERILE LACERATION & DEBRIDEMENT TRAYS
K934029 · LRO
Surgipro, Inc.
General & Plastic Surgery · 171d
Cleared Feb 04, 1994
MONOJECT VERTICAL ENTRY SHARPS CONTAINER
K934404 · FMI
Sherwood Medical Co.
General Hospital · 148d
Cleared Feb 04, 1994
CU-FREE & LTA
K934757 · EJS
Jeneric/Pentron, Inc.
Dental · 123d
Cleared Feb 04, 1994
FASCINATION CERAMIC BRACKET
K935139 · EJF
Dentauraum, Inc.
Dental · 99d
Cleared Feb 04, 1994
DENTAURUM STEEL LIGATURE WIRES
K935140 · DZC
Dentauraum, Inc.
Dental · 99d
Cleared Feb 04, 1994
DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS
K935144 · ECI
Dentauraum, Inc.
Dental · 99d
Cleared Feb 04, 1994
MERSHON BAND PUSHER
K935155 · ECS
Dentauraum, Inc.
Dental · 99d
Cleared Feb 04, 1994
SHARPSAFE CAT. NO. 4127
K935628 · FMI
Smiths Industries Medical Systems, Inc.
General Hospital · 73d