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
137881–137904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1987
STRATUM D
K874697 · LDD
Alternative Design Systems, Inc.
Cardiovascular · 26d
Cleared Dec 14, 1987
SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL
K872254 · HHR
Surgical Laser Technologies, Inc.
Obstetrics & Gynecology · 208d
Cleared Dec 14, 1987
DIFFERENTIAL I.M. SCREENING TEST
K873297 · KTN
Sclavo, Inc.
Immunology · 118d
Cleared Dec 14, 1987
PARAMAX CALCIUM REAGENT
K873519 · CIC
Baxter Healthcare Corp
Chemistry · 104d
Cleared Dec 14, 1987
PARAMAX MAGNESIUM REAGENT
K873530 · JGJ
Baxter Healthcare Corp
Chemistry · 104d
Cleared Dec 14, 1987
MEDATRON CUVETTE DISC
K873656 · JRI
Medatron, Inc.
Chemistry · 95d
Cleared Dec 14, 1987
PARAMAX ISE CHLORIDE CALIBRATOR
K873743 · JIT
Baxter Healthcare Corp
Chemistry · 89d
Cleared Dec 14, 1987
GUAZE SPONGES
K874067 · EFQ
Interpro Intl., Inc.
General & Plastic Surgery · 70d
Cleared Dec 14, 1987
REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE
K874099 · KGO
Biopro, Inc.
General Hospital · 67d
Cleared Dec 14, 1987
MULTI-FUNCTION BLOOD GAS CONTROL
K874408 · JJS
Bionostics, Inc.
Chemistry · 47d
Cleared Dec 14, 1987
MODEL V4 AUDIOMETER
K874516 · EWO
Digital Hearing Systems Corp.
Ear, Nose, Throat · 42d
Cleared Dec 14, 1987
HI-TOUCH (TM) BRAND SURGICAL GLOVES
K874539 · KGO
Apex Medical Technologies, Inc.
General Hospital · 41d
Cleared Dec 14, 1987
I.M.N. LATEX
K874678 · KTN
Biokit USA, Inc.
Immunology · 31d
Cleared Dec 14, 1987
E600B FOOTSWITCH
K874794 · BWA
Valleylab, Inc.
General & Plastic Surgery · 21d
Cleared Dec 11, 1987
EUB-410 DIAGNOSTIC ULTRASOUND DEVICE
K871004 · IYO
Hitachi Medical Corp. of America
Radiology · 274d
Cleared Dec 11, 1987
HERPES 1 AND 2 MICROASSAYS
K871420 · GGC
Diamedix Corp.
Microbiology · 247d
Cleared Dec 11, 1987
CUSTOM PROCEDURE TRAYS
K871616 · FMF
Medical Custom Products, Inc.
General Hospital · 228d
Cleared Dec 11, 1987
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM
K872125 · CCE
C.R. Bard, Inc.
Anesthesiology · 192d
Cleared Dec 11, 1987
FIBERLASE II ND:YAG LASER FOR PULMONARY USE
K872351 · LLO
Laser Media
Anesthesiology · 177d
Cleared Dec 11, 1987
LOVIEL CONDOM
K872861 · HIS
Lloviel Marketing Corp.
Obstetrics & Gynecology · 143d
Cleared Dec 11, 1987
THERMOWRAP, A/K/A/, THERMAL WRAP
K873254 · IRT
Family Sun Tanning
Physical Medicine · 116d
Cleared Dec 11, 1987
TECNOL COMPRESSION KNEE DRESSING
K873368 · LLK
Tecnol New Jersey Wound Care, Inc.
General Hospital · 112d
Cleared Dec 11, 1987
INSTITUTIONAL BILI LIGHT (IBL)
K873700 · LBI
Physician Engineered Products, Inc.
General Hospital · 88d
Cleared Dec 11, 1987
SAFETY SHIELD SUCTION CATHETER
K873810 · BSY
Ballard Medical Products
Anesthesiology · 84d