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
124129–124152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1990
KODAK X-MAT 270 RA PROCESSOR
K904238 · IXW
Eastman Kodak Company
Radiology · 19d
Cleared Oct 03, 1990
PS MEDICAL CRANIAL HAND DRILL
K904283 · HBG
Pudenz-Schulte Medical Research Corp.
Neurology · 16d
Cleared Oct 03, 1990
LATEX EXAMINATION GLOVE
K904324 · LYY
Gallimore Ent., Inc.
General Hospital · 19d
Cleared Oct 02, 1990
ENTERAL PUMP SET WITH ENTERAL SPIKE
K895142 · KNT
Delmed, Inc.
Gastroenterology & Urology · 412d
Cleared Oct 02, 1990
600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA
K895329 · KNT
Delmed, Inc.
Gastroenterology & Urology · 397d
Cleared Oct 02, 1990
ENTERAL PUMP SET W/ENTERA-FLO SPIKE
K895650 · KNT
Delmed, Inc.
Gastroenterology & Urology · 377d
Cleared Oct 02, 1990
THE OPHTHIMUS SYSTEM
K896017 · DQK
Hightech Vision
Cardiovascular · 351d
Cleared Oct 02, 1990
MODEL IS102S ND:YAG SURGICAL LASER SYSTEM
K902133 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 145d
Cleared Oct 02, 1990
CATARRHALIS TEST STRIP
K902595 · JTO
Remel Co.
Microbiology · 112d
Cleared Oct 02, 1990
BLAKE MEDICAL BREATHING TUBE SUPPORT
K902604 · CBH
Blake Medical, Inc.
Anesthesiology · 112d
Cleared Oct 02, 1990
PEGASUS W/ACCESSORIES FOR GENERAL SURGERY
K902946 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 89d
Cleared Oct 02, 1990
PEGASUS W/ACCESSORIES FOR ARTHROSCOPIC APPLICATION
K902947 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 89d
Cleared Oct 02, 1990
COHERENT HOLMIUM:YAG SURGICAL LASER
K902990 · GEX
Coherent Medical Division
General & Plastic Surgery · 85d
Cleared Oct 02, 1990
PEGASUS WITH ACCESSORIES
K903027 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 84d
Cleared Oct 02, 1990
ELECTRODE, ELECTROSURGERY
K903302 · JOS
Megadyne Medical Products, Inc.
General & Plastic Surgery · 70d
Cleared Oct 02, 1990
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K903435 · JOH
Shiley, Inc.
Anesthesiology · 63d
Cleared Oct 02, 1990
ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST
K903556 · MDE
Gen-Probe, Inc.
Microbiology · 56d
Cleared Oct 02, 1990
QUIDEL CHLAMYDIA POSITIVE CONTROL
K903765 · LJC
Quidel Corp.
Microbiology · 46d
Cleared Oct 02, 1990
IMMUNODOT THYROID AUTOIMMUNITY PANEL
K903843 · JNL
General Biometrics, Inc.
Chemistry · 42d
Cleared Oct 02, 1990
ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.
K904047 · MDF
Gen-Probe, Inc.
Microbiology · 28d
Cleared Oct 02, 1990
DISCRENE SELF-SUPPORTING BREAST FORM
K904086 · KCZ
Coloplast A/S
General & Plastic Surgery · 27d
Cleared Oct 02, 1990
SUTURE TENSION ADJUSTMENT REEL
K904136 · KGS
Surgical Systems, Inc.
General & Plastic Surgery · 26d
Cleared Oct 02, 1990
BAUMAN CPR/RESUSCITATOR
K904346 · BTM
General Medical Products, Inc.
Anesthesiology · 8d
Cleared Oct 01, 1990
N-A-G TEST KIT
K893582 · CGX
Ppr Diagnostics , Ltd.
Chemistry · 510d