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
131209–131232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1989
CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE
K892521 · FZS
Cymed, Inc.
General & Plastic Surgery · 20d
Cleared Apr 28, 1989
SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI
K883670 · GNP
Electro-Nucleonics, Inc.
Microbiology · 253d
Cleared Apr 28, 1989
LATEX NON-STERILE EXAM GLOVES
K890496 · LYY
Cal-American Exports, Inc.
General Hospital · 92d
Cleared Apr 28, 1989
SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS)
K890513 · OLZ
Micro Tronics Corp.
Neurology · 86d
Cleared Apr 28, 1989
GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K890789 · LNH
Philips Medical Systems North...
Radiology · 72d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVES
K890965 · LYY
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 60d
Cleared Apr 28, 1989
PHYNE-TOUCH (PATIENT EXAMINATION GLOVES)
K890983 · LYY
Medical Resources, Ltd.
General Hospital · 60d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891147 · LYY
Glove Seal Sdn Bhd
General Hospital · 56d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891158 · LYY
Golden Earth Corp.
General Hospital · 53d
Cleared Apr 28, 1989
SUMMIT PATIENT EXAMINATION GLOVE
K891171 · LYY
Terng Nan Industrial Corp.
General Hospital · 53d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891325 · LYY
Getah Gayal (M) Sdn Bhd
General Hospital · 46d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891353 · LYY
Audra, Inc.
General Hospital · 46d
Cleared Apr 28, 1989
LATEX EXAMINATION GLOVES, STYLE 510 LX
K891420 · LYY
C & K Mfg. & Sales Co.
General Hospital · 45d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891498 · LYY
Carneal Enterprises, Inc. Div....
General Hospital · 43d
Cleared Apr 28, 1989
ARG LATEX EXAMINATION GLOVES
K891510 · LYY
Palmbase Rubber Mfg. (M) Sdn Bhd
General Hospital · 43d
Cleared Apr 28, 1989
DYNATEX PATIENT EXAMINATION GLOVES (LATEX)
K891797 · LYY
Azteca Intl., Inc.
General Hospital · 36d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891979 · LYY
Jeanine Alcantara Intl.
General Hospital · 30d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891980 · LYY
Montrose Intl., Corp.
General Hospital · 30d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892009 · LYY
Glovco Malaysia Sdn Bhd
General Hospital · 29d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892074 · LYY
Perusahaan Intan Emas Sdn. Bhd.
General Hospital · 25d
Cleared Apr 28, 1989
SINTON LATEX EXAMINATION GLOVE
K892090 · LYY
Sinton Latex Chemical Industries Co.,...
General Hospital · 25d
Cleared Apr 28, 1989
CHAMP-PAQ VINYL PATIENT EXAM GLOVES
K892098 · LYZ
Winmed Instruments Mfg. Corp.
General Hospital · 25d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892105 · LYY
Essence Rubber Products Sdn Bhd
General Hospital · 25d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892133 · LYY
Limattan Corp.
General Hospital · 24d