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
103033–103056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 1995
H292
K942820 · KIR
Bartels, Inc.
Pathology · 324d
Cleared May 05, 1995
NEEDLE ELCTRODE
K944265 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 246d
Cleared May 05, 1995
ACUTRAK PLUS FIXATION SYSTEM
K944330 · HWC
Acu Med, Inc.
Orthopedic · 241d
Cleared May 05, 1995
VSP (VARIABLE SCREW PLACEMENT)
K944736 · MNH
Acromed Corp.
Orthopedic · 221d
Cleared May 05, 1995
TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA
K945318 · ITX
Tetra Corp.
Radiology · 185d
Cleared May 05, 1995
CIBA CORNING ACS CORTISOL IMMUNOASSAY
K945367 · CGR
Ciba Corning Diagnostics Corp.
Chemistry · 221d
Cleared May 05, 1995
KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
K945685 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 165d
Cleared May 05, 1995
AQUALARM MOISTURE SENSOR MODEL P85000
K946057 · BYH
Pegasus Research Corp.
Anesthesiology · 144d
Cleared May 05, 1995
CONSENSUS(TM) ORTHOPEDIC DRILL BIT
K950013 · HWE
U.S. Medical Products, Inc.
Orthopedic · 122d
Cleared May 05, 1995
THE GRIESHABER AXIAL CUTTER
K950056 · HKP
Grieshaber & Co.
Ophthalmic · 119d
Cleared May 05, 1995
B-L RED(TM) DISCS
K950346 · JTO
Oxis Intl., Inc.
Microbiology · 98d
Cleared May 05, 1995
VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER
K950432 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 92d
Cleared May 05, 1995
CANNUAL AND TROCAR, SUPERPUBIC
K950457 · HET
Core Dynamics, Inc.
Obstetrics & Gynecology · 91d
Cleared May 05, 1995
OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES
K950626 · GKZ
Immunotech Corp.
Hematology · 84d
Cleared May 05, 1995
KIS-V PRE-ANGULATED AND WIDE BODY ABUTMENTS
K950893 · DZE
The Implant Center of the Palm Beaches
Dental · 66d
Cleared May 05, 1995
CAPITOL URINE DRUG SCREEN COLLECTION KIT
K951122 · KDW
Harry A. Schlakman
Chemistry · 67d
Cleared May 05, 1995
SMALL FRAGMENT PLATES AND SCREWS
K951302 · JDS
Medpac
Orthopedic · 44d
Cleared May 05, 1995
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
K951361 · LCP
Heraeus Kulzer, Inc.
Chemistry · 39d
Cleared May 05, 1995
MINIBONEPLATE SYSTEM
K951392 · JEY
Ace Surgical Supply Co., Inc.
Dental · 45d
Cleared May 05, 1995
SPECTRUM CURING LIGHT POLYMERIZATION UNIT
K951425 · EBZ
Dentsply Intl.
Dental · 39d
Cleared May 04, 1995
WALLACH LEAP 100 ELECTRO SURGERY SYSTEM
K921791 · HGI
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 1115d
Cleared May 04, 1995
EXTRA PROTECTION POLYURETHANE CONDOM
K922688 · MOL
Apex Medical Technologies, Inc.
Obstetrics & Gynecology · 1064d
Cleared May 04, 1995
VAGINAL CONTINENCE DEVICE
K930618 · HHW
Johnson & Johnson Medical, Inc.
Obstetrics & Gynecology · 815d
Cleared May 04, 1995
ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER
K933417 · DRF
Echocath, Inc.
Cardiovascular · 660d