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
138049–138072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 1987
COL. CNA 5% SB/MACCONKEY AGAR BIPLATE # Z3206
K873479 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Oct 08, 1987
TSA 5% SHEEP BLOOD/EMB AGAR - PRODUCT #Z3023
K873480 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Oct 08, 1987
HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016
K873481 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Oct 08, 1987
TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z3033
K873482 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Oct 08, 1987
TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z3020
K873483 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Oct 08, 1987
PEDIATRIC BELLOWS
K873549 · CBK
Draeger Medical, Inc.
Anesthesiology · 38d
Cleared Oct 08, 1987
DIGIVIEWER
K873646 · LLZ
Digivision, Inc.
Radiology · 30d
Cleared Oct 08, 1987
BAHIA ALLERGEN DISC
K873648 · DHB
Incstar Corp.
Immunology · 29d
Cleared Oct 08, 1987
MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C)
K873827 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 17d
Cleared Oct 07, 1987
PULSE-OX
K863857 · DQA
Life Design Systems, Inc.
Anesthesiology · 370d
Cleared Oct 07, 1987
MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS.
K871990 · OLZ
Oxford Medilog, Inc.
Neurology · 134d
Cleared Oct 07, 1987
MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER
K872138 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 126d
Cleared Oct 07, 1987
CODMAN NEUROLASE LASER SYSTEM
K872179 · GEX
Codman & Shurtleff, Inc.
General & Plastic Surgery · 121d
Cleared Oct 07, 1987
MODIFIED PHADEBAS RAST/PHADEZYM RAST
K872280 · DHB
Pharmacia, Inc.
Immunology · 113d
Cleared Oct 07, 1987
OHMEDA BIOX 3740 PULSE OXIMETER
K872772 · DQA
Ohmeda Medical
Anesthesiology · 85d
Cleared Oct 07, 1987
MODEL 2240 SLAVE SCOPE
K873346 · DPS
Marquette Electronics, Inc.
Cardiovascular · 49d
Cleared Oct 07, 1987
SUTURELESS TEMPORARY EPICARDIAL PACING LEAD
K873474 · LDF
Symbion, Inc.
Cardiovascular · 37d
Cleared Oct 07, 1987
RED TOP ALLERGEN DISC
K873486 · DHB
Incstar Corp.
Immunology · 37d
Cleared Oct 07, 1987
SILENT GUARD CAT. NO. SG-10
K873488 · DTL
American Omni Medical, Inc.
Cardiovascular · 37d
Cleared Oct 07, 1987
ACA URINE DRUGS OF ABUSE CONTROL
K873539 · DIF
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 36d
Cleared Oct 07, 1987
CIBA CORNING MAGIC LITE FERRITIN
K873573 · DBF
Ciba Corning Diagnostics Corp.
Immunology · 35d
Cleared Oct 07, 1987
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K873668 · CEP
Medix Biotech, Inc.
Chemistry · 27d
Cleared Oct 07, 1987
IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT
K873676 · DHB
Incstar Corp.
Immunology · 23d
Cleared Oct 07, 1987
PULL-APART INTRODUCER (SHEATH)
K873727 · DYB
Quinton, Inc.
Cardiovascular · 28d