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
120913–120936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1991
FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS
K911907 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 69d
Cleared Jul 08, 1991
PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT
K912231 · JHW
Intl. Immunoassay Laboratories, Inc.
Chemistry · 49d
Cleared Jul 08, 1991
AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM
K912651 · FYD
Stackhouse Assoc.
General Hospital · 21d
Cleared Jul 05, 1991
BUD DENTAL IMPLANT SYSTEM
K902331 · DZE
Bud Industries, Inc.
Dental · 407d
Cleared Jul 05, 1991
ACETATE-FREE DIALYSLATE SOLUTION
K903835 · KPO
Physio, Inc.
Gastroenterology & Urology · 318d
Cleared Jul 05, 1991
EASY EYES TM CONTACT LENS CLEANING MACHINE
K904824 · LYL
Eaton Medical Corp.
Ophthalmic · 253d
Cleared Jul 05, 1991
SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA
K910985 · GCJ
Precision Laser Products, Inc.
General & Plastic Surgery · 121d
Cleared Jul 05, 1991
PICC-FIX
K911070 · KMK
Sorex Medical
General Hospital · 116d
Cleared Jul 05, 1991
PAL (PROBE FOR ASPIRATION AND LAVAGE)
K911149 · GCJ
Marlo Surgical Technology
General & Plastic Surgery · 112d
Cleared Jul 05, 1991
REICH SUCTION/IRRIGATION CANNULA
K911164 · GCJ
Marlo Surgical Technology
General & Plastic Surgery · 112d
Cleared Jul 05, 1991
PULPDENT ORTHODONTIC BRACKET ADHESIVE
K911286 · DYH
Pulpdent Corp.
Dental · 108d
Cleared Jul 05, 1991
HARDING STERNAL SHIELD
K911407 · EYF
Harding Medical Devices
General & Plastic Surgery · 98d
Cleared Jul 05, 1991
MAGNUM-MEIER RECANALIZATION GUIDEWIRE
K911547 · DQX
Schneider Intl., Ltd.
Cardiovascular · 88d
Cleared Jul 05, 1991
ZEPHYR INFUSION CATHETER
K911560 · DQO
Target Therapeutics
Cardiovascular · 88d
Cleared Jul 05, 1991
CHEMOTHERAPY CONTAINER
K911576 · KPE
Bemis Mfg. Co.
General Hospital · 88d
Cleared Jul 05, 1991
DISPOSABLE SURGICAL TROCAR WITH SEAL
K911589 · GCJ
Applied Vascular Devices, Inc.
General & Plastic Surgery · 87d
Cleared Jul 05, 1991
INNOFLUOR(TM) VALPROIC ACID REAGENT SET
K911688 · LEG
Intl. Bioclinical, Inc.
Toxicology · 80d
Cleared Jul 05, 1991
ACCU-VENT(TM) WITH NEEDLE-PRO(TM)
K912043 · CBT
Concord/Portex
Anesthesiology · 58d
Cleared Jul 04, 1991
HH-1119 HEALING HEAD
K903515 · DZE
Minimatic Implant Technology
Dental · 335d
Cleared Jul 03, 1991
COLOCARE
K905798 · KHE
Helena Laboratories
Hematology · 226d
Cleared Jul 03, 1991
NEUROCAM
K910967 · IYX
GE Medical Systems
Radiology · 119d
Cleared Jul 03, 1991
COLOSCREEN
K911075 · KHE
Helena Laboratories
Hematology · 114d
Cleared Jul 03, 1991
PHILIPS URO DIAGNOST MRF
K911098 · IXR
Philips Medical Systems, Inc.
Radiology · 113d
Cleared Jul 03, 1991
ALL-PRO 100
K911291 · IXW
All-Pro Imaging Corp.
Radiology · 100d