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
127513–127536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1990
DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AID
K896159 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 22, 1990
ASC-954 INTEGRATOR AMPLIFIER
K896164 · GWK
Astro-Med, Inc.
Neurology · 90d
Cleared Jan 22, 1990
HERRICK LACRIMAL PLUG TM.
K896175 · LZU
Lacrimedics, Inc.
Ophthalmic · 89d
Cleared Jan 22, 1990
SAFE-T-CAP NEEDLE COVER
K896219 · DZM
Ausmedics Pty , Ltd.
Dental · 87d
Cleared Jan 22, 1990
BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY
K896315 · BTT
Bear Medical Systems, Inc.
Anesthesiology · 82d
Cleared Jan 22, 1990
BABYFLEX HEATED INFANT BREATHING CIRCUIT
K896365 · CAI
Baxter Healthcare Corp
Anesthesiology · 77d
Cleared Jan 22, 1990
PORGES NASOBILIARY DRAIN
K896376 · FGE
Porges Corp.
Gastroenterology & Urology · 77d
Cleared Jan 22, 1990
URETERAL ACCESS SET
K896385 · KOD
Applied Urology, Inc.
Gastroenterology & Urology · 77d
Cleared Jan 22, 1990
PORGES BILIARY STENTS
K896423 · FGE
Porges Corp.
Gastroenterology & Urology · 75d
Cleared Jan 22, 1990
PORGES SPHINCTEROTOMES
K896426 · KNS
Porges Corp.
Gastroenterology & Urology · 75d
Cleared Jan 22, 1990
DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD
K896475 · IYT
Medipart Jerry Alexander
Radiology · 70d
Cleared Jan 22, 1990
DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD
K896476 · IYT
Medipart Jerry Alexander
Radiology · 70d
Cleared Jan 22, 1990
PORGES BIOPSY & FOREIGN BODY FORCEPS
K896502 · OCZ
Porges Corp.
Gastroenterology & Urology · 68d
Cleared Jan 22, 1990
TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.
K896510 · CBN
Technical Medical Products, Inc.
Anesthesiology · 69d
Cleared Jan 22, 1990
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K896547 · JOH
Bivona Medical Technologies
Anesthesiology · 68d
Cleared Jan 22, 1990
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K896548 · JOH
Bivona Medical Technologies
Anesthesiology · 68d
Cleared Jan 22, 1990
MUCOUS TRAP
K896560 · BSY
Westmark, Sterile Packing Systems,...
Anesthesiology · 66d
Cleared Jan 22, 1990
ACCESS(TM), SOFTWARE RELEASE 4.11P
K896637 · LPH
Diasonics, Inc.
Radiology · 59d
Cleared Jan 22, 1990
EXT-600 TABLE, RADIOGRAPHIC, ELEVATING
K896665 · IZZ
Rms Div.
Radiology · 56d
Cleared Jan 22, 1990
COMPACT VIDEO IMAGER MP4000 SERIES III
K896683 · LMC
International Imaging Electronics
Radiology · 55d
Cleared Jan 22, 1990
MODEL 7-AT TREATMENT CHAMBER
K896721 · LGM
J. H. Emerson Co.
General Hospital · 55d
Cleared Jan 22, 1990
FILT-R-ALL BACTERIAL FILTER
K896832 · CAH
Inhalation Plastics
General Hospital · 48d
Cleared Jan 22, 1990
L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP
K896936 · GXY
Labeltape Meditect, Inc.
Neurology · 40d
Cleared Jan 22, 1990
TRIMODE SP DENTAL INTRA ORAL X-RAY
K896963 · EAP
Tempo Technology, Inc.
Radiology · 38d