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
121489–121512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1991
TASSI MK3 (TURNAIR)
K910851 · IOQ
Therapy Air Support Systems, Inc.
Physical Medicine · 76d
Cleared May 15, 1991
PROTEKT GLOVES
K910920 · FYE
Intermedics Orthopedics
General & Plastic Surgery · 71d
Cleared May 15, 1991
29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM
K911068 · EFB
Micro Motors, Inc.
Dental · 65d
Cleared May 15, 1991
SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR
K911072 · EHZ
A & F Products
Dental · 65d
Cleared May 15, 1991
MERCURY AND GLASS FEVER THERMOMETER
K911269 · FLK
Steridyne Corp.
General Hospital · 54d
Cleared May 15, 1991
PULPDENT PIC N STIC
K911281 · EKJ
Pulpdent Corp.
Dental · 57d
Cleared May 15, 1991
BUFFING FLOSS
K911470 · JES
Lamar Industries
Dental · 42d
Cleared May 15, 1991
TOKUSO LIGHT BOND
K911525 · KLE
Tokuyama America, Inc.
Dental · 40d
Cleared May 15, 1991
ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN
K911558 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 37d
Cleared May 15, 1991
CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION
K911578 · CHH
Cholestech Corp.
Chemistry · 49d
Cleared May 15, 1991
VISION BG MONITOR
K911596 · CGA
British-American Medical, Inc.
Chemistry · 36d
Cleared May 15, 1991
MIRCOLINE SCREEN FOR COCAINE
K911652 · DIO
Drug Screening Systems, Inc.
Toxicology · 33d
Cleared May 15, 1991
G-FLOSS & G-FLOSS II
K911701 · JES
Implant Innovations International, Inc.
Dental · 29d
Cleared May 15, 1991
STRATUS(R) AUTOMATED SAMPLE HANDLER
K911712 · JQW
Baxter Healthcare Corp
Chemistry · 28d
Cleared May 15, 1991
FIRST CHOICE(TM), MODIFICATION
K911792 · CGA
Polymer Technology Corp.
Chemistry · 23d
Cleared May 15, 1991
HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED
K911803 · JJY
Hichem Diagnostics
Chemistry · 22d
Cleared May 15, 1991
CEDIA(R) DIGOXIN R' ASSAY
K911941 · KXT
Microgenics Corp.
Toxicology · 14d
Cleared May 14, 1991
DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)
K902607 · GWF
Dantec Medical, Inc.
Neurology · 336d
Cleared May 14, 1991
TENS CONDUCTIVE MEDIA PAD
K904889 · GYB
Creative Design Systems, Inc.
Neurology · 204d
Cleared May 14, 1991
PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM
K905397 · CCE
Puritan Bennett Corp.
Anesthesiology · 165d
Cleared May 14, 1991
SPARK KIT(R), MODIFICATION
K910142 · FPA
Lyphomed, Inc.
General Hospital · 120d
Cleared May 14, 1991
PATHFINDER
K910601 · HPG
Nurion Industries
Ophthalmic · 90d
Cleared May 14, 1991
AP-860PA NIBP MODULE
K910629 · DQA
Nihon Kohden America, Inc.
Anesthesiology · 90d
Cleared May 14, 1991
504US PULSE OXIMETER
K910770 · DQA
Criticare Systems, Inc.
Anesthesiology · 81d