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
134377–134400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1988
ELGILOY
K883074 · EBL
Dale T. Dupuis
Dental · 26d
Cleared Aug 08, 1988
VERIMED MYO/PREMS
K874212 · IPF
Verimed Holdings, Inc.
Physical Medicine · 297d
Cleared Aug 08, 1988
CLEAR EYE GARTER SHIELD
K880489 · HOY
Eye Garter Company, Inc.
Ophthalmic · 186d
Cleared Aug 08, 1988
SOLID PHASE EXTRACTION TUBES
K881361 · DJY
Supelco, Inc.
Toxicology · 174d
Cleared Aug 08, 1988
TELSTETH TELEMETRIC STETHOSCOPE(TM)
K882119 · DXH
Quantsonics, Inc.
Cardiovascular · 81d
Cleared Aug 08, 1988
COTUBE HCG IRMA TEST
K882155 · JHI
Bio-Rad
Chemistry · 80d
Cleared Aug 08, 1988
REVISED DOUBLE ANTIBODY AMPHETAMINE
K882228 · DJP
Diagnostic Products Corp.
Toxicology · 81d
Cleared Aug 08, 1988
MAGNESIUM REAGENT SET
K882256 · JGJ
Tech-Neal Scientific, Inc.
Chemistry · 69d
Cleared Aug 08, 1988
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA
K882340 · CEP
Serono Diagnostics, Inc.
Chemistry · 62d
Cleared Aug 08, 1988
REP HDL ELECTROPHORESIS METHOD
K882368 · LBT
Helena Laboratories
Chemistry · 61d
Cleared Aug 08, 1988
CLEANTECH SYSTEM
K882539 · JKA
Schiff & Co.
Chemistry · 48d
Cleared Aug 08, 1988
PROFILE ONE OMNI
K882559 · JJE
Modular Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Aug 08, 1988
A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM
K882586 · CIC
A-Kem, Inc.
Chemistry · 46d
Cleared Aug 08, 1988
A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM
K882587 · CIX
A-Kem, Inc.
Chemistry · 46d
Cleared Aug 08, 1988
EMIT HVA BARBITURATE ASSAY
K882611 · DIS
Syva Co.
Toxicology · 45d
Cleared Aug 08, 1988
PHARMACIA IGE RIA ULTRA
K882625 · DGC
Pharmacia, Inc.
Chemistry · 42d
Cleared Aug 08, 1988
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719 · LDP
Em Diagnostic Systems, Inc.
Toxicology · 38d
Cleared Aug 08, 1988
AMERLITE TOTAL THYROID CONTROL SERA LAN.4001
K882727 · JJY
Amersham Corp.
Chemistry · 38d
Cleared Aug 08, 1988
OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM
K882812 · JDI
Osteonics Corp.
Orthopedic · 32d
Cleared Aug 08, 1988
EMIT HVA CANNABINOID 100 NG ASSAY
K882819 · LDJ
Syva Co.
Toxicology · 31d
Cleared Aug 08, 1988
WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM
K882890 · JDQ
Thackray USA
Orthopedic · 28d
Cleared Aug 08, 1988
SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)
K882962 · GEH
Spembly Medical , Ltd.
General & Plastic Surgery · 25d
Cleared Aug 08, 1988
SPEMBLY MEDICAL 142 CRYO UNIT
K882963 · GEH
Spembly Medical , Ltd.
General & Plastic Surgery · 25d
Cleared Aug 08, 1988
IMX CKMB
K883013 · JHY
Abbott Laboratories
Chemistry · 20d