Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
137785–137808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1987
TEMPORARY DISCLOSING SOLUTION
K874074 · KLE
Dentsply Intl.
Dental · 84d
Cleared Dec 29, 1987
RF DIPSTICK TEST KIT
K874151 · DHR
Lipogen, Inc.
Immunology · 77d
Cleared Dec 29, 1987
CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK.
K874158 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 77d
Cleared Dec 29, 1987
BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE
K874186 · LDQ
Busse Hospital Disposables, Inc.
General & Plastic Surgery · 76d
Cleared Dec 29, 1987
BARD OCTAPOLAR ELECTRODE CATHETER
K874208 · DRF
C.R. Bard, Inc.
Cardiovascular · 75d
Cleared Dec 29, 1987
STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET
K874226 · EJF
Advanced Orthodontics Systems, Inc.
Dental · 74d
Cleared Dec 29, 1987
PLASTIC BRACKETS
K874227 · DYW
Advanced Orthodontics Systems, Inc.
Dental · 74d
Cleared Dec 29, 1987
CLEANING BRUSH
K874239 · MNL
Endovations
Gastroenterology & Urology · 74d
Cleared Dec 29, 1987
ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET
K874293 · KOD
Ackrad Laboratories
Gastroenterology & Urology · 70d
Cleared Dec 29, 1987
AUTOCHUCK ATTACHMENT
K874294 · EFB
Den-Tal-Ez Mfg Co., Inc.
Dental · 70d
Cleared Dec 29, 1987
ACKRAD RETROGRADE URETHROGRAPHY SET
K874312 · KOD
Ackrad Laboratories
Gastroenterology & Urology · 70d
Cleared Dec 29, 1987
EXPLORER-DENTAL PROBER
K874335 · EKJ
Military Engineering, Inc.
Dental · 68d
Cleared Dec 29, 1987
BTE HEARING AID OTICON MODEL E38P
K874380 · ESD
Oticon Corp.
Ear, Nose, Throat · 64d
Cleared Dec 29, 1987
A SERIES OF 7 INCH CONTINUOUS INFUSION SETS
K874403 · FPA
Quinton, Inc.
General Hospital · 62d
Cleared Dec 29, 1987
LIQUI-SERA SPINAL FLUID CONTROL
K874459 · JJY
Biodiagnostic Intl
Chemistry · 61d
Cleared Dec 29, 1987
MICRO-AIRE PULSE LAVAGE
K874504 · FQH
Micro-Aire Surgical Instruments, Inc.
General Hospital · 57d
Cleared Dec 29, 1987
DESERET SPLITTABLE CATHETER
K874582 · FOZ
Deseret Medical, Inc.
General Hospital · 50d
Cleared Dec 29, 1987
BENT NECK CURLCATH PERITONEAL DIALYSIS KIT
K874632 · FKX
Quinton, Inc.
Gastroenterology & Urology · 50d
Cleared Dec 29, 1987
GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS
K874878 · LSK
Gen-Probe, Inc.
Microbiology · 29d
Cleared Dec 23, 1987
H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK.
K873908 · HIT
Richmond Products, Inc.
Ophthalmic · 89d
Cleared Dec 23, 1987
GUIDE WIRE BOWL
K873942 · DQX
Condor Medical
Cardiovascular · 86d
Cleared Dec 23, 1987
2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN
K874025 · EBI
Astron Dental Corp.
Dental · 82d
Cleared Dec 23, 1987
DEVILBISS MODEL 8500D
K874041 · CAF
The Devilbiss Co.
Anesthesiology · 79d
Cleared Dec 23, 1987
OPHTHALMIC TIP & BLADE SCALPELS
K874057 · HNN
Myocure, Inc.
Ophthalmic · 79d