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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121321–121344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1991
VIBROMETRY SYSTEM
K901881 · LNN
Bruel & Kjaer Instruments, Inc.
Gastroenterology & Urology · 400d
Cleared May 31, 1991
RHEUMAGEN RF T-CONTROL
K904310 · DHR
Biokit USA, Inc.
Immunology · 254d
Cleared May 31, 1991
VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.
K904813 · EBF
Alpha-Dent
Dental · 218d
Cleared May 31, 1991
IV EXTENSION SETS WITH .22 MICRON FILTER
K905374 · FPA
Marquette Medical, Inc.
General Hospital · 183d
Cleared May 31, 1991
MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING
K905464 · CBT
Angiosystems, Inc.
Anesthesiology · 177d
Cleared May 31, 1991
VOLUMETRIC INFUSION PUMP
K910024 · FRN
Baxter Healthcare Corp
General Hospital · 148d
Cleared May 31, 1991
SPLINTER TWEEZERS
K910570 · FSM
Solan Scissors Sales
General & Plastic Surgery · 109d
Cleared May 31, 1991
ENDOPATH SURGICAL INSTRUMENTS
K910831 · GEI
Symbiosis Corp.
General & Plastic Surgery · 93d
Cleared May 31, 1991
INFUSION PUMP
K910844 · FRN
Technology Transfer Intl., Inc.
General Hospital · 93d
Cleared May 31, 1991
T600 TREADMILL
K910867 · IOL
Siemens Burdick, Inc.
Physical Medicine · 91d
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