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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
157633–157656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1983
SPUNGUARD SCRUB SUIT
K831207 · FXO
Kimberly-Clark Corp.
General Hospital · 34d
Cleared May 16, 1983
GENTAMICIN CALIBRATOR -ACA
K831209 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 32d
Cleared May 16, 1983
MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450
K831226 · GEC
Ballard Medical Products
General & Plastic Surgery · 31d
Cleared May 16, 1983
LED GOGGLES
K831231 · HLX
Cadwell Laboratories, Inc.
Ophthalmic · 31d
Cleared May 16, 1983
LITHIUM HEPARINIZED BLOOD COLLECT-TUBE
K831242 · JKA
American Dade
Hematology · 31d
Cleared May 16, 1983
SAFE-SEAT WHEELCHAIR CUSHION
K831247 · KIC
D.A. Schulman, Inc.
Physical Medicine · 28d
Cleared May 16, 1983
DISPOSABLE MICROTOME BLADE
K831308 · IDL
Surgipath Medical Industries, Inc.
Pathology · 24d
Cleared May 16, 1983
BRACE C.T.
K831310 · ITQ
Innovation Sports, Inc.
Physical Medicine · 24d
Cleared May 16, 1983
DISPOSABLE BASE MOLD
K831335 · KER
Surgipath Medical Industries, Inc.
Pathology · 21d
Cleared May 16, 1983
STREPTOCOCUS ID PLATE
K831349 · JST
Granite Diagnostics, Inc.
Microbiology · 21d
Cleared May 16, 1983
TESTCORP ASO
K831363 · GTQ
Catheter Technology Corp.
Microbiology · 20d
Cleared May 13, 1983
MUMPSELISA TEST KIT
K830045 · LJY
M.A. Bioproducts
Microbiology · 123d
Cleared May 13, 1983
FIRST AID KIT
K830373 · FRO
Akla, Inc.
General & Plastic Surgery · 98d
Cleared May 13, 1983
RESCUE PACK
K830374 · KDD
Akla, Inc.
General & Plastic Surgery · 98d
Cleared May 13, 1983
SYSMEX CC-170
K830507 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 85d
Cleared May 13, 1983
CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK
K830563 · CGR
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 79d
Cleared May 13, 1983
STRATUS PHENOBARBITAL FLUOROMETRIC ENZ
K830701 · LET
American Dade
Toxicology · 67d
Cleared May 13, 1983
YIELD NON-ADHERENT DRESSING
K830825 · FRO
Professional Medical Products, Inc.
General & Plastic Surgery · 59d
Cleared May 13, 1983
S & W MODEL ASO
K830873 · KNC
S & W Enterprises, Inc.
Obstetrics & Gynecology · 56d
Cleared May 13, 1983
MF 380 ELECTROSURGICAL UNIT
K830925 · GEI
Zimmer, Inc.
General & Plastic Surgery · 51d
Cleared May 13, 1983
HELENA BIOSTRIP A
K830978 · JMA
Helena Laboratories
Chemistry · 45d
Cleared May 13, 1983
BIOLOGIC SYSTEM BL 101
K831047 · GWE
Bio-Logic Systems Corp.
Neurology · 43d
Cleared May 13, 1983
CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE
K831219 · JSK
Gibco Laboratories Life Technologies,...
Microbiology · 28d
Cleared May 13, 1983
TILL-U-TEST G.C. GONOCOCUS SLIDE
K831268 · JTY
Pasco Laboratories, Inc.
Microbiology · 25d