FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
121921–121944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1991
SURGICA(TM) H
K910898 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 88d
Cleared May 31, 1991
JAIN SUTURE PACKAGE COUNTER
K911077 · MMK
Jain Surgical Equipment, Inc.
General Hospital · 81d
Cleared May 31, 1991
ERA 2000A
K911261 · BTL
Neotronics, Inc.
Anesthesiology · 70d
Cleared May 31, 1991
DIRECTIGEN 1-2-3 PREGNANCY CONTROLS
K911664 · JJX
Quidel Corp.
Chemistry · 49d
Cleared May 31, 1991
RAMP RAT
K911986 · ITI
Vehicle Dynamics
Physical Medicine · 25d
Cleared May 30, 1991
ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL
K896596 · IZH
Instrumentarium Imaging, Inc.
Radiology · 555d
Cleared May 30, 1991
MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE
K901810 · BSP
Neuro Technology
Anesthesiology · 405d
Cleared May 30, 1991
COM-TENS: A NEUROSTIMULATOR
K902102 · GZJ
Apex Medical, Inc.
Neurology · 387d
Cleared May 30, 1991
RIVER MEDICAL MICRODRILL SYSTEM
K905437 · EQH
River Medical, Inc.
Ear, Nose, Throat · 177d
Cleared May 30, 1991
ULTRALITE PANELITE
K910091 · IOB
Ultralite
Physical Medicine · 141d
Cleared May 30, 1991
MICREL LTD-PORTABLE INFUSION PUMP-MP20Q
K910350 · FRN
Technology Transfer Intl., Inc.
General Hospital · 122d
Cleared May 30, 1991
COMPUTE-RX-COMP (TM)
K910367 · KPQ
Medicalibration Physics Consultant...
Radiology · 121d
Cleared May 30, 1991
MICREL LTD - PORTABLE INFUSION MICROPUMP-MP11
K910758 · FRN
Technology Transfer Intl., Inc.
General Hospital · 122d
Cleared May 30, 1991
FACEPLATE ITE HEARING AID MODEL TCA
K910900 · LRB
Telex Communications, Inc.
Ear, Nose, Throat · 86d
Cleared May 30, 1991
FACEPLATE ITE HEARING AID MODEL 28A
K910901 · LRB
Telex Communications, Inc.
Ear, Nose, Throat · 86d
Cleared May 30, 1991
JAIN QUICK COUNT
K911076 · MMK
Jain Surgical Equipment, Inc.
General Hospital · 80d
Cleared May 30, 1991
PULPDENT DIAMOND POLISH
K911284 · EJR
Pulpdent Corp.
Dental · 90d
Cleared May 30, 1991
MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION
K911642 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 49d
Cleared May 30, 1991
ZEFON BATERIAL/VIRAL FILTER
K911651 · CAH
Bill Olson Corp.
General Hospital · 48d
Cleared May 30, 1991
HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE
K911667 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 48d
Cleared May 30, 1991
THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST
K911821 · EJH
Dentecon, Inc.
Dental · 36d
Cleared May 30, 1991
ZERO-G(TM) GEL/FOAM MATTRESS TOPPER
K911843 · KIC
Steridyne Corp.
Physical Medicine · 35d
Cleared May 30, 1991
BARD SINGULAR BIOPSY FORCEPS
K912214 · FCL
C.R. Bard, Inc.
Gastroenterology & Urology · 10d
Cleared May 29, 1991
VENA CAVA FILTER
K901454 · DTK
Vena-Tech, Inc.
Cardiovascular · 428d