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
156793–156816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 13, 1983
CLOSTRIDIUM DIFFICLE MEDIA
K831279 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 14d
Cleared May 09, 1983
PRO-SCOPE
K822085 · FER
Exitec, Inc.
Gastroenterology & Urology · 300d
Cleared May 09, 1983
MEDIGROUP LS-110 LIGHT SOURCE
K823294 · HET
Medigroup
Obstetrics & Gynecology · 185d
Cleared May 09, 1983
SEPTOPACK
K830113 · EMA
North Pacific Dental, Inc.
Dental · 118d
Cleared May 09, 1983
CUSTOM IV SET
K830182 · FPA
Custom Medical, Inc.
General Hospital · 111d
Cleared May 09, 1983
PROTET SOAP & WASH MITT
K830259 · GED
Ritmed, Inc.
General & Plastic Surgery · 104d