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
78169–78192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2001
LATEX EXAMINATION GLOVES- POWDER FREE, BLUE
K011712 · LYY
Pt.Shamrock Manufacturing Corp.
General Hospital · 43d
Cleared Jul 17, 2001
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
K011853 · JJY
Bio-Rad
Immunology · 34d
Cleared Jul 17, 2001
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K011883 · LYZ
Shijiazhuang Eversharp Plastic...
General Hospital · 29d
Cleared Jul 17, 2001
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K011884 · LYZ
Shijiazhuang Eversharp Plastic...
General Hospital · 29d
Cleared Jul 17, 2001
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
K011982 · FOZ
Bd
General Hospital · 21d
Cleared Jul 16, 2001
AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX,...
K010008 · GZB
Micronet Medical, Inc.
Neurology · 195d
Cleared Jul 16, 2001
LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW
K011076 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 98d
Cleared Jul 16, 2001
VIADUCT MICROENDOSCOPE AND ACCESSORIES
K011189 · GCJ
Acueity, Inc.
General & Plastic Surgery · 89d
Cleared Jul 16, 2001
BIOPSY SITE MARKER
K011402 · FZP
Senorx, Inc.
General & Plastic Surgery · 70d
Cleared Jul 16, 2001
CAVEX COLORCHANGE
K011419 · ELW
Cavex Holland BV
Dental · 68d
Cleared Jul 16, 2001
SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT...
K011525 · JLW
Biosafe Laboratories, Inc.
Chemistry · 60d
Cleared Jul 16, 2001
CONCORD 72
K011626 · EJT
Gateway Alloys, Inc.
Dental · 48d
Cleared Jul 16, 2001
CONCORD 82
K011628 · EJT
Gateway Alloys, Inc.
Dental · 48d
Cleared Jul 16, 2001
SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K011885 · LYZ
Shijiazhuang Eversharp Plastic...
General Hospital · 28d
Cleared Jul 16, 2001
MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
K011955 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 24d
Cleared Jul 16, 2001
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
K011976 · JWH
Exactech, Inc.
Orthopedic · 21d
Cleared Jul 13, 2001
METAL TRANSCEND ARTICULATION SYSTEM
K004043 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 196d
Cleared Jul 13, 2001
POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
K010051 · JDR
Xiros Plc
Orthopedic · 186d
Cleared Jul 13, 2001
SUPREMA POWERED WHEELCHAIR
K010600 · ITI
Luigi Chinetti
Physical Medicine · 135d
Cleared Jul 13, 2001
MALLEABLE SHAFT CLAMP
K011078 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 95d
Cleared Jul 13, 2001
ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)
K011257 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 80d
Cleared Jul 13, 2001
RAMBLER
K011401 · INI
Rambler Mobility, Inc.
Physical Medicine · 67d
Cleared Jul 13, 2001
MODEL 100 ACTIVITY MONITOR
K011429 · GYD
Telecom Medical, Inc.
Neurology · 65d
Cleared Jul 13, 2001
MEDLINE GROUNDING PAD
K011515 · JOS
Medline Industries, Inc.
General & Plastic Surgery · 57d